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Ministry Status: Recovery


The ministry is resuming regular operations and supporting health sector stabilization.

Drug Submissions

Status For Single-Source Submissions

Brand Name and Indication

Generic Name and Strength

Date Published

Status

Abilify
Schizophrenia and related psychotic disorders

aripiprazole
2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablet

19/10/2011

First Review Completed

Abilify
For major depressive disorder

aripiprazole
2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablet

27/10/2015

First Review Completed

Abilify Maintena
For the maintenance treatment of schizophrenia in stabilized adult patients

aripiprazole
300 mg/vial and 400 mg/vial powder for suspension, SR (IM)

04/08/2015

First Review Completed

Aptivus
For the treatment of HIV/AIDS according to clinical criteria.

tirpranavir
250 mg capsule

29/04/2022

First Review Completed

Abraxane
Metastatic breast cancer

paclitaxel
100 mg/vial powder for injection

30/06/2011

Reconsideration Completed

Abraxane
Metastatic pancreatic cancer

nab-paclitaxel
100 mg/vial powder for injection

05/05/2015

First Review Completed

Abevmy
Antineoplastic

BEVACIZUMAB
25 mg/mL (400 mg/16 mL) and 25 mg/mL (100 mg/4 mL) IV solution, single use vial

29/04/2022

First Review Completed

ATECTURA BREEZHALER
Indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older with reversible obstructive airways disease

Indacaterol (as acetate)/ mometasone furoate
150 mcg/80 mcg, 150 mcg/160 mcg, 150 mcg/320 mcg inhalation powder hard capsules use vial

28/02/2022

First Review Completed

Abraxane for Injectable Suspension
Metastatic breast cancer

paclitaxel
100 mg/vial

30/06/2011

Reconsideration Completed

Abstral
For breakthrough pain in patients with cancer, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain

fentanyl citrate
100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg sublingual tablet

03/04/2012

First Review Completed

Accel-Sevelamer
For the treatment of hyperphosphatemia according to clinical criteria.

sevelamer carbonate
800 mg FC tablet

17/04/2020

First Review Completed

Accu-Chek Guide Test Strips
To measure the concentration of glucose in the blood

FAD glucose dehydrogenase (GDH)

08/08/2017

First Review Completed

Accu-Chek Inform ll Glucose Test Strips
To measure the concentration of glucose in the blood

quinoprotein glucose dehydrogenase

25/03/2014

First Review Completed

Accu-Chek Mobile
To measure the concentration of glucose in the blood

glucose oxi-reductase

27/10/2015

Reconsideration Completed

Accu-Chek Performa Test Strips
To measure the concentration of glucose in the blood

glucose dehydrogenase

04/01/2012

Withdrawn

Actemra
Moderate to severe rheumatoid arthritis

tocilizumab
80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL intravenous solution

23/01/2014

Reconsideration Completed

Actemra
Polyarticular Juvenile Idiopathic Arthritis (pJIA)

tocilizumab
20 mg/mL concentrate solution for infusion

17/06/2015

First Review Completed

Actemra
Reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who have inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF) antagonists

tocilizumab
162 mg/0.9 mL subcutaneous solution

27/10/2015

First Review Completed

Actemra
For the treatment of giant cell arteritis (GCA) in adult patients

tocilizumab
162 mg/0.9 mL subcutaneous solution

17/04/2019

First Review Completed

Actemra
For the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and giant cell arteritis according to clinical criteria.

tocilizumab
162 mg / 0.9 mL subcutaneous solution, single-use prefilled autoinjector

31/03/2020

First Review Completed

Actemra
For the treatment of patients with Polyarticular Juvenile Idiopathic Arthritis (pJIA).

tocilizumab
162 mg/ 0.9 mL SC solution, single-use prefilled syringe

26/02/2020

First Review Completed

Actemra SC
For use of subcutaneous (SC) administration of Actemra for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with one or more non-steroidal anti-inflammatory drugs and systemic corticosteroids.

tocilizumab
162 mg/ 0.9 mL SC solution, pre-filled syringe (PFS) and autoinjector device (AI) (the addition of a new route of administration).

44140

First Review Completed

Actikerall
For the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (Grade I/II) of the face, forehead, and balding scalp in immunocompetent adult patients

fluorouracil & salicyclic acid
0.5 %/10 % w/w solution

24/10/2018

First Review Completed

Actonel
Osteoporosis

risedronate sodium
150 mg tablet

16/06/2009

First Review Completed

Actonel DR
Treatment and prevention of osteoporosis

risedronate sodium
35 mg DR tablet

17/02/2012

First Review Completed

Acuvail
For the treatment of pain and inflammation following cataract surgery

ketorolac tromethamine
0.45 % w/v ophthalmic solution

23/04/2013

First Review Completed

Adalat XL Plus
For use in patients for whom treatment of both nifedipine and acetylsalicylic acid is appropriate

nifedipine/acetylsalicylic acid
20 mg/81 mg, 30 mg/81 mg and 60 mg/81 mg ER tablet

26/03/2009

File Closed

Adcetris
The treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates

brentuximab vedotin
50 mg lyophilized powder

20/02/2014

First Review Completed

Adcetris
For the post-Autologous Stem Cell Transplant (ASCT) consolidation treatment of patients with Hodgkin Lymphoma (HL) at increased risk of relapse or progression

brentuximab vedotin
50 mg lyophilized powder

17/12/2019

First Review Completed

Adcetris
For patients after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates.

brentuximab vedotin
50 mg lyophilized powder

20/02/2019

File Closed

Adcetris
For the post-Autologous Stem Cell Transplant (ASCT) consolidation treatment of patients with Hodgkin Lymphoma (HL) at increased risk of relapse or progression

brentuximab vedotin
50 mg lyophilized powder

17/12/2019

First Review Completed

Adcetris
For patients after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates.

brentuximab vedotin
50 mg lyophilized powder

20/02/2019

File Closed

Adcetris
For the treatment of previously untreated peripheral T-cell lymphoma (PTCL) according to clinical criteria.

brentuximab vedotin
50 mg/vial powder for solution

10/11/2020

First Review Completed

Adcetris
For the treatment of adult patients with CD30-positive primary cutaneous anaplastic large cell lymphoma (pcALCL) or mycosis fungoides (MF) according to clinical criteria

brentuximab vedotin
50 mg/vial powder for solution

09/12/2021

First Review Completed

Adcetris
In combination with AVD, be reimbursed for the treatment of previously untreated patients with Stage IV HL

brentuximab vedotin
50 mg lyophilized powder for injection

04/11/2021

First Review Completed

Adcirca
Pulmonary arterial hypertension

tadalafil
20 mg tablet

21/03/2011

First Review Completed

Adempas
For the management of inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) and persistent or recurrent CTEPH after surgical treatment in adult patients (≥18 years of age) with WHO Functional Class II or III pulmonary hypertension

riociguat
0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg FC tablet

27/10/2015

First Review Completed

Adempas
As monotherapy or in combination with endothelin receptor antagonists (ERAs) in adult patients (≥18 years of age) with WHO Functional Class II or III pulmonary hypertension

riociguat
0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg tablet

26/06/2018

First Review Completed

Adlyxine
For once-daily in combination with a basal insulin alone, or in combination with metformin, for the treatment of adults with Type 2 diabetes who are uncontrolled on basal insulin therapy

lixisenatide
0.05 mg/mL (10 mcg/dose),
0.1 mg/mL (20 mcg/dose)
single-use pre-filled pen,
0.05 mg/mL & 0.1 mg/mL
(10 mcg/dose & 20 mcg/dose)
starter kit SC solution

20/12/2019

First Review Completed

Admelog
Anti-Diabetic Agent

insulin lispro
100 units/mL solution for injection

18/12/2020

First Review Completed

Advagraf
Prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants

tacrolimus
3 mg capsule

21/03/2011

First Review Completed

Aermony RESPICLICK
The maintenance treatment of steroid-responsive bronchial asthma as prophylactic therapy in patients 12 years of age and older

fluticasone propionate
55 mcg, 113 mcg and 232 mcg dry powder for inhalation

29/03/2021

First Review Completed

Afinitor
Treatment of metastatic renal cell carcinoma (mRCC)

everolimus
10 mg tablet

21/03/2011

First Review Completed

Afinitor
For the treatment of adult patients (≥ 18 years of age) with renal angiomyolipoma associated with tuberous sclerosis complex (TSC), who do not require immediate surgery

everolimus
2.5 mg, 5 mg and 10 mg tablet

27/10/2015

First Review Completed

Afinitor
The treatment of Subependymal Giant Cell Astrocytoma (SEGA) associated with Tuberous Sclerosis Complex

everolimus
2.5 mg, 5 mg and 10 mg tablet

18/06/2018

First Review Completed

Afinitor
For the treatment of unresectable, locally advanced or metastatic well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal or lung origin in adults with progressive disease

everolimus
2.5 mg, 5 mg and 10 mg tablet

23/11/2017

First Review Completed

Afinitor
Treatment of neuroendocrine tumours of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease

everolimus
2.5 mg, 5 mg and 10 mg tablet

31/07/2013

First Review Completed

Afinitor
Treatment of post menopausal women in combination with exemestane after progression or recurrence (failure) with non-steroidal aromatase inhibitor therapy

everolimus
2.5 mg, 5 mg and 10 mg tablets

27/10/2015

First Review Completed

Aimovig
Prevention of migraine in adults who have at least 8 migraine days per month and who have previously failed, are intolerant, or have a contraindication to at least two migraine preventive therapies

erenumab
70 mg/mL and 140 mg/mL pre-filled autoinjector

24/09/2019

File Closed

Ajovy
For the prevention of migraine in adults who have at least 4 migraine days per month

fremanezumab
150 mg/mL, subcutaneous solution

03/03/2022

First Review Completed

Ajovy
For the prevention of migraine in adults who have at least 4 migraine days per month

fremanezumab
225 mg/1.5 mL (150mg/mL) SC solution, single dose prefilled autoinjector

09/06/2022

First Review Completed

Aybintio
Antineoplastic

BEVACIZUMAB
25 mg/mL (100mg/4 mL) and 25 mg/mL (400mg/16mL) single use vial

15/07/2022

First Review Completed

Albrioza
For the treatment of people living with amyotrophic lateral sclerosis (ALS) who have been diagnosed by a specialist experienced in the diagnosis and management of ALS and who are not currently requiring permanent non-invasive or invasive ventilation

sodium phenylbutyrate and ursodoxicoltaurine
3 g/ 1 g oral sachet, powder for suspension

21/06/2022

Active

Bijuva
Treatment of moderate to severe vasomotor symptoms associated with menopause in women with intact uterus

ESTRADIOL, PROGESTERONE
0.5 mg, 100 mg and 1 mg, 100 mg capsule

08/03/2022

Active

Akynzeo
For the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy. For the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone

netupitan & palonosetron
300 mg & 0.5 mg capsule

28/06/2019

First Review Completed

Alecensaro
As monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancers (NSCLC) who have progressed on or are intolerant to crizotinib and have CNS metastases

alectinib HCl
150 mg capsule

17/04/2019

First Review Completed

Alecensaro
A monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC)

alectinib HCl
150 mg capsule

15/08/2018

Active

Alimta
Second-line treatment of non-small cell lung cancer

pemetrexed
100 mg/vial

01/03/2010

First Review Completed

Alimta
First-line treatment of non-small cell lung cancer

pemetrexed
500 mg/vial

10/07/2009

First Review Completed

Alimta
Maintenance treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer

pemetrexed
100 mg/vial and 500 mg/vial

04/01/2012

Second Review Completed

Alimta
As monotherapy for the maintenance treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer

pemetrexed
100 mg/500 mg vial IV powder for solution

27/10/2015

First Review Completed

Allevia Plus Blood Glucose Strips
To measure the concentration of glucose in the blood

FAD-glucose dehydrogenase

28/03/2017

Active

Aloxi
Prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy

palonosetron
0.5 mg capsule

29/08/2013

First Review Completed

Aloxi
Prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy

palonosetron
0.5 mg capsule

31/07/2015

File Closed

Alunbrig
As a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC) who have progressed on or who were intolerant to an ALK inhibitor (crizotinib)

brigatinib
30 mg, 90 mg, 180 mg tablet, and 90 mg/ 180 mg starter pack, tablet.

10/02/2022

First Review Completed

Alunbrig
For the treatment of anaplastic lymphoma kinase–positive locally advanced or metastatic non-small cell lung cancer according to clinical criteria

brigatinib
30 mg, 90 mg, 180 mg tablet, and 90 mg/ 180 mg starter pack, tablet.

10/02/2022

First Review Completed

Arazlo
For the treatment of acne vulgaris

TAZAROTENE
0.045 % lotion

31/10/2022

First Review Completed

Amgevita
Polyarticular Juvenile Idiopathic Arthritis, Hidradenitis Suppurativa, Uveitis, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult Crohn’s Disease, Pediatric Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Pediatric Uveitis

ADALIMUMAB
50 mg/mL solution for SC injection, prefilled syringe and autoinjector

29/03/2021

First Review Completed

Amgevita
For inducing and maintaining clinical remission in pediatric patients 5 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine (6-MP) or who are intolerant to such therapies

ADALIMUMAB
50 mg/mL solution for SC injection, prefilled syringe and autoinjector

07/11/2022

Active

Androderm
Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism)

testosterone
24.3 mg transdermal patch

20/02/2014

First Review Completed

Anoro Ellipta
For the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema

umeclidinium bromide/ vilanterol trifenatate
62.5mcg/ 25mcg/ powder for oral inhalation

29/06/2015

First Review Completed

Apidra
Diabetes, Type 1 & 2

insulin glulisine
100 U/mL injection solution – 10 mL vial and 3 mL pack

21/08/2009

First Review Completed

Apidra
Diabetes, Type 1 & 2

insulin glulisine
100 U/mL solution – 3 mL cartridge (ClickStar pen)

01/06/2010

First Review Completed

Aptiom
As adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy who are not satisfactory controlled with conventional therapy

eslicarbazepine acetate
200 mg/ 400 mg / 600 mg / 800 mg tablet

25/11/2015

First Review Completed

Arbesda
For the treatment asthma in patients aged 12 years and older.

fluticasone propionate & salmeterol
55 mcg/ 14 mcg, 113 mcg/ 14 mcg, and 232/ 14 mcg, dry-powder inhaler

12/02/2020

Active

Arnuity Ellipta
For the once-daily maintenance treatment of steroid-responsive bronchial asthma in patients aged 12 years and older

fluticasone furoate
100 mcg (per actuation) and 200 mcg (per actuation) powder (oral inhalation)

29/09/2016

First Review Completed

Axiron
For testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism)

testosterone
2% topical solution metered-dose pump/30 mg (1.5 mL) per actuation

24/06/2015

First Review Completed

Arzerra
In combination with chlorambucil, for the patients with chronic lympocytic leukemia (CLL) who have not received prior therapy and for whom fludarabine-based therapy is considered appropriate

ofatumumab
20 mg/mL IV solution

24/06/2015

First Review Completed

Asmanex Twisthaler
For the prophylactic management of steroid-response bronchial asthma in patients 12 years of age and older

mometasone furoate dry powder inhaler
200 mcg and 400 mcg metered inhalation

02/01/2013

First Review Completed

Asmanex Twisthaler
As a preventative agent for the prophylactic management of steroid-responsive bronchial asthma in patients 4 years of age and older

mometasone furoate dry powder inhaler
100 mcg/ metered inhalation

27/10/2015

Active

Atacand
Hypertension

candesartan cilexetil
32 mg tablet

20/05/2009

First Review Completed

Atacand Plus
Hypertension

candesartan cilexetil/hydrochlorothiazide
32 mg/12.5 mg and 32 mg/25 mg tablet

20/08/2010

First Review Completed

ATECTURA BREEZHALER
Indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older with reversible obstructive airways disease.

Indacaterol (as acetate)/ mometasone furoate
150 mcg/ 80 mcg, 150 mcg/ 160 mcg, 150 mcg/ 320 mcg inhalation powder hard capsules

28/02/2022

First Review Completed

Adtralza
For the treatment of adult patients with moderate-to-severe AD whose
disease is not adequately controlled with topical prescription therapies or when those
therapies are not advisable and who had an adequate trial or be ineligible for each of
the following therapies: phototherapy (where available), methotrexate, and cyclosporine.

TRALOKINUMAB
150 mg/mL SC Solution

23/12/2021

Active

Abrilada
Biological Response Modifier

ADALIMUMAB
50 mg mL SC solution for injection, prefilled pen and prefilled syringe

31/05/2022

First Review Completed

Aubagio
As monotherapy for the treatment of patients with relapsing remitting multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability

teriflunomide
14 mg tablet

24/11/2014

First Review Completed

Avastin
Metastatic breast cancer

bevacizumab
100 mg/4 mL vial and 400 mg/ 16 mL vial IV solution

05/07/2011

Reconsideration Completed

Avastin
Advanced metastatic or recurrent non-squamous non-small cell lung cancer

bevacizumab
100 mg/4 mL vial and 400 mg/ 16 mL vial IV solution

30/06/2010

First Review Completed

Avastin
For treatment of patients with recurrent glioblastoma multiforme (GBM)

bevacizumab
100 mg/ 4mL SD Vial (25 mg/ mL) and 400 mg/ 16 mL (25 mg/ mL) IV solution

28/01/2014

Reconsideration Completed

Avastin
In combination with paclitaxel, topotecan or pegylated liposomal doxorubicin for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens

bevacizumab
25 mg/mL solution for injection

03/05/2016

First Review Completed

Avastin
In combination with chemotherapy for the treatment of patients with persistent, recurrent or metastatic carcinoma of the cervix

bevacizumab
25 mg/mL IV solution

18/06/2018

First Review Completed

Avastin
In combination with paclitaxel and carboplatin for front-line treatment of epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high risk of relapse (stage III sub-optimally debulked or stage III unresectable, or stage IV patients)

bevacizumab with paclitaxel & carboplatin
25 mg/mL IV solution

18/06/2018

First Review Completed

Avonex Pen
Treatment of relapsing forms of multiple sclerosis

interferon beta - 1a
30mcg/ 0.5mL subcutaneous prefilled autoinjector or pen

19/10/2011

First Review Completed

Avsola
Rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, plaque psoriasis.

infliximab
100 mg / vial powder for solution (IV)

18/12/2020

First Review Completed

Axiron
For testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism)

testosterone
2 % topical solution metered-dose pump/30 mg (1.5 mL) per actuation

24/06/2015

First Review Completed

Azarga
Elevated intraocular pressure therapy

brinzolamide/timolol maleate
1 %/0.5 % ophthalmic suspension

30/06/2010

First Review Completed

Bambevi
For the treatment of various cancer conditions according to clinical criteria.

bevacizumab
100 mg/4 mL, 400 mg/16 mL injection solution

15/12/2021

First Review Completed

Breztri Aerosphere
For the long-term maintenance treatment to reduce exacerbations of chronic obstructive pulmonary disease (COPD) and treat airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema who are not adequately treated by a combination of an ICS/LABA or a combination of a LAMA/LABA

BUDESONIDE/FORMOTEROL FUMARATE DIHYDRATE/GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE)
182 mcg/5.8 mcg/ 8.2 mcg per ACT, PRESSURIZED INHALATION SUSPENSION, Aerosol, Metered Dose

31/10/2022

First Review Completed

Banzel
For adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults

rufinamide
100 mg, 200 mg and 400 mg tablet

25/07/2012

First Review Completed

Basaglar
For once-daily subcutaneous administration in the treatment of patients over 17 years of age with type 1 or type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. The treatment of pediatric patients (>6 years old) with type 1 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.

insulin glargine (rDNA origin)
100 units /mL/ SC solution

31/08/2017

First Review Completed

Bimzelx
For the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

BIMEKIZUMAB
160 mg/mL SC, solution for injection, pre-filled syringe and autoinjector

17/03/2022

Active

Basaglar Kwikpen
For once-daily subcutaneous administration in the treatment of patients over 17 years of age with type 1 or type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia

insulin glargine
80 units/ injection, solution for injection (100 IU/ mL)

21/03/2019

First Review Completed

Bavencio
Treatment of metastatic Merkel Cell Carcinoma (mMCC) in previously treated adults

avelumab
20 mg/mL solution for intravenous infusion

18/04/2019

First Review Completed

Bavencio
For the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed with platinum-based induction chemotherapy.

avelumab
20 mg/mL solution for infusion

12/05/2022

First Review Completed

Benlysta
In addition to standard therapy for reducing disease activity in adult patients with active, autoantibody-positive, systemic lupus erythematosis (SLE)

BELIMUMAB
120 mg/ vial and 400 mg/ vial lyophilized powder for IV infusion

27/05/2013

Reconsideration Completed

Benlysta
In addition to standard therapy for reducing disease activity in adult patients with active autoantibody positive systemic Lupus Erythematosus (SLE)

BELIMUMAB
200 mg in 1mL solution for SC injection

15/11/2019

Active

Benlysta
For the treatment of active lupus nephritis in adult patients in addition to standard therapy

BELIMUMAB
120 mg/vial and 400 mg/vial lyophilized powder for IV infusion

01/12/2022

Active

Beovu
For the treatment of neovascular (wet) age-related macular degeneration
(AMD).

BROLUCIZUMAB
120 mg/mL solution for intravitreal injection

17/12/2021

First Review Completed

Beovu
For the treatment of diabetic macular edema

BROLUCIZUMAB
6 mg / 0.05 mL solution for intravitreal injection

04/01/2023

Active

Baqsimi
For the treatment of severe hypoglycemia (SH) reactions in patients with diabetes mellitus who are receiving insulin therapy and are at high risk for SH, when impaired consciousness precludes oral carbohydrate.

GLUCAGON
3 mg glucagon per device (3 mg/dose), nasal powder – intranasal

31/01/2022

First Review Completed

Besponsa
Treatment of relapsed or refractory (R/R) B-Cell precursor acute lymphoblastic Leukemia (ALL)

inotuzumab ozogamicin
1 mg powder for solution for infusion

23/08/2019

First Review Completed

Betaseron Initiation Pack
Clinically isolated syndrome (CIS) and clinically definite multiple sclerosis (CDMS)

interferon beta-1b
0.3 mg/vial powder for solution

24/08/2011

First Review Completed

Bryhali
For the topical treatment of corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis.

HALOBETASOL PROPIONATE
0.01 % w/w topical lotion

21/03/2022

Active

BGStar Blood Glucose Test Strip
To measure the concentration of glucose in the blood

glucose oxidase
2.7IU

06/09/2012

First Review Completed

Biktarvy
As a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with no known substitution associated with resistance to the individual components of BIKTARVY.

bictegravir/ emtricitabine/ tenofovir alafenamide
50 mg/200 mg/ 25 mg tablet

02/11/2018

Active

Blincyto
For the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B precursor acute lymphoblastic leukemia (ALL)

blinatumomab
38.5 µg lyophilized powder for solution for infusion

23/05/2017

First Review Completed

Blincyto
For the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)

blinatumomab
38.5 µg lyophilized powder for solution for infusion

08/08/2017

Active

Blincyto
For the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL).

blinatumomab
38.5 mcg, single-use vials, lyophilized powder for solution for infusion

25/02/2020

First Review Completed

Blincyto
Patients with Philadelphia chromosome-negative CD19 positive B-precursor acute lymphoblastic leukemia (ALL) in first or second hematologic complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

blinatumomab
38.5 mcg/vial lyophilized powder for solution

28/08/2021

First Review Completed

Bosulif
For the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior TKI therapy, and for whom subsequent treatment with imatinib, nilotinib and dasatinib is not clinically appropriate.

bosutinib
100 mg and 500 mg tablet

26/06/2018

First Review Completed

Botox
Management of strabismus, blepharospasm, cervical dystonia and spasticity

clostridium botulinum toxin type A
200 units/vial

26/07/2011

Reconsideration Completed

Botox
For the treatment of blepharospasm, strabismus, cervical dystonia, focal spasticity, dynamic equinus foot deformity

clostridium botulinum toxin type A
50 units/vial

26/07/2011

First Review Completed

Botox
For the treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from neurogenic bladder associated with multiple sclerosis or subcervical spinal cord injury in adults who had an inadequate response to or are intolerant of anticholinergic medications

clostridium botulinum toxin type A
50 units/vial, 100 units/vial and 200 units/vial

02/01/2013

First Review Completed

Botox
For the prophylaxis of headaches in adults with chronic migraine

clostridium botulinum toxin type A
50 units/vial, 100 units/vial and 200 units/vial

22/01/2015

First Review Completed

Botox
For the treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of anticholinergic medication

onabotulinumtoxinA
50 units/vial, 100 units/vial and 200 units/vial

27/10/2015

First Review Completed

Botox
Criteria Change Request: Prophylaxis of headaches in adults with chronic migraine

onabotulinumtoxinA
50 units/vial, 100 units/vial and 200 units/vial

05/07/2018

First Review Completed

Botox
Treatment for prophylaxis of headaches in adults with chronic migraine (> 15 days per month with headaches lasting 4 hours a day or longer).

onabotulinumtoxinA
50 unit/vial, 100 unit/vial, and 200 unit/vial powder for injection

06/06/2019

Active

Mektovi and Braftovi
BRAFTOVI and MEKTOVI in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation

BINIMETINIB and ENCORAFENIB
15 mg tablet and 75 mg capsule

06/12/2022

First Review Completed

Braftovi
In combination with cetuximab, for the treatment of patients with metastatic colorectal cancer with a BRAF V600E mutation, after prior therapy

ENCORAFENIB
75 mg capsule

06/12/2022

First Review Completed

Bravo Blood Glucose Test Strip
To measure the concentration of glucose in the blood

glucose oxidase
2.7 units

26/06/2018

File Closed

Brenzys
Rheumatoid arthritis and ankylosing spondylitis

etanercept
50 mg/mL solution (subcutaneous) pre-filled syringe and 50 mg/mL solution (subcutaneous) pre-filled auto-injector

09/08/2017

First Review Completed

Brenzys
Expanded indications of plaque psoriasis in adults and children, psoriatic arthritis in adults and juvenile idiopathic arthritis.

etanercept
50 mg/mL, solution for injection (prefilled syringe and prefilled autoinjector)

29/03/2021

First Review Completed

Breo Ellipta
Is indicated for the long-term once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)

fluticasone furoate/vilanterol trifenatate
100 mcg/25 mcg dry powder for oral inhalation

27/10/2015

First Review Completed

Breo Ellipta
For the once-daily maintenance treatment of asthma in patients aged 18 years and older with reversible obstructive airways disease

fluticasone furoate/vilanterol trifenatate
100 mcg/25 mcg & 200 mcg/25 mcg, dry powder for oral inhalation

26/06/2018

First Review Completed

Brilinta
Secondary prevention of atherothrombotic events in patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event

ticagrelor
60 mg tablet

28/03/2017

Active

Brilinta, Pre-Notice of Compliance
Prevention of thrombotic events in patients with Acute Coronary Syndromes

ticagrelor
90 mg tablet

23/04/2013

Reconsideration Completed

Brineura
For the treatment of Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) disease/ tripeptidyl peptidase 1 (TPP1) deficiency, in patients who meet clinical criteria.

cerliponase alfa
150 mg/5 mL (30 mg/mL) solution for Infusion for Intracerebroventricular Infusion

29/11/2019

First Review Completed

Brivlera
As adjunctive therapy in the management of partial-onset seizures in adult patients with epilepsy who are not satisfactorily controlled with conventional therapy

brivaracetam
10 mg, 25 mg, 50 mg, 75 mg, 100 mg tablet

14/12/2018

First Review Completed

BuTrans
Management of persistent pain of moderate intensity in adults requiring continuous opioid analgesia for an extended period of time

buprenorphine
5 mcg/hr, 10 mcg/hr and 20 mcg/hr transdermal patch

17/05/2012

Second Review Completed

Byetta
In combination with metformin and/or a sulfonylurea to improve glycemic control in patients with type 2 diabetes mellitus

exenatide
250 µg/mL subcutaneous solution for injection

22/10/2012

First Review Completed

Bystolic
For the treatment of mild to moderate essential hypertension

nebivolol
2.5 mg, 5 mg, 10 mg and 20 mg tablet

18/07/2014

Reconsideration Completed

Byooviz

  • For the treatment of neovascular (wet) age-related macular degeneration (AMD).
  • For the treatment of visual impairment due to diabetic macular edema (DME).
  • For the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO).
  • For the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM).
  • For the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to ocular conditions other than AMD or PM, including but not limited to angioid streaks, post-inflammatory retinochoroidopathy, central serous chorioretinopathy or idiopathic chorioretinopathy

RANIBIZUMAB
10 mg/mL solution (intravitreal injection)

28/11/2022

Active

Cablivi
For the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange (PE) and immunosuppressive therapy

CAPLACIZUMAB
11 mg/vial powder for solution (IV or SC)

21/09/2022

Active

Cabenuva
As a complete regimen for the treatment of Human Immunodeficiency Virus-Type 1 (HIV-1) infection in adult patients to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (virologic suppression is defined as HIV-1 ribonucleic acid [RNA] level [viral load] of less than 50 copies/mL); Response to treatment with Cabenuva, defined as ongoing virologic suppression (as defined above), should be assessed every 6 months;
Treatment should be discontinued if there is evidence of,
– Sustained loss of virologic suppression (as defined above); OR
– Development of resistance to, adverse events leading to lack of tolerability of,and/or lack of adherence to either component of the drug regimen;
The prescriber must be approved for the Facilitated Access to HIV/AIDS Drug Products mechanism

cabotegravir & rilpivirine
200 mg/mL & 300 mg/mL injection solution

30/11/2021

First Review Completed

Cabometyx
For advanced hepatocellular carcinoma (HCC) in patients who have previously been treated

cabozatinib
20 mg, 40 mg and 60 mg tablet

29/12/2021

First Review Completed

Cabometyx
For the treatment of adult patients with advanced renal cell carcinoma who have received prior therapy

cabozatinib
20 mg, 40 mg, 60 mg FC tablet

01/04/2019

Active

Calquence
Monotherapy for patients with chronic lymphocytic leukemia (CLL) who have received at least one therapy.

acalabrutinib
100 mg capsule

03/12/2021

First Review Completed

Calquence
In combination with obinutuzumab or as monotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia.

acalabrutinib
100 mg capsule

3/12/2021

First Review Completed

Caprelsa
For the treatment of symptomatic or progressive medullary thyroid cancer in adult patients with unresectable locally advanced or metastatic disease

vandetanib
100 mg and 300 mg tablet

24/10/2018

First Review Completed

CareSens N Blood Glucose Test Strip
To measure the concentration of glucose in the blood

glucose oxidase

04/08/2015

First Review Completed

Caripul
For the long-term intravenous treatment of primary pulmonary hypertension and secondary pulmonary hypertension due to scleroderma spectrum of diseases in NYHA functional Class III and Class IV patients who did not respond adequately to conventional therapy

epoprostenol sodium
0.5 mg / 1.5 mg per vial

16/01/2014

First Review Completed

Cayston
Management of cystic fibrosis (CF) patients with chronic pulmonary Pseudomonas aeruginosa infections

aztreonam
75 mg/vial powder for solution

21/09/2012

First Review Completed

Celsentri
Treatment experienced patients infected with HIV

maraviroc
150 mg and 300 mg tablet

25/02/2009

First Review Completed

Celsentri
For treatment naïve HIV-infection

maraviroc
150 mg and 300 mg tablet

05/10/2011

First Review Completed

Cesamet
Management of nausea and vomiting associated with cancer therapy

nabilone
0.25 mg capsule

10/07/2009

First Review Completed

 

 Cibinqo
For the treatment of patients 12 years and older with refractory moderate to severe atopic dermatitis (AD), including the relief of pruritus, who have had an inadequate response to other systemic drugs (e.g. steroid or biologic), or for whom these treatments are not advisable

 

ABROCITINIB
50 mg, 100 mg & 200 mg tablet

26/08/2022

Active

Cimzia
Moderate to severe active rheumatoid arthritis (RA)

certolizumab pegol
200 mg/mL pre-filled syringe

01/10/2010

First Review Completed

Cimzia
For reducing signs and symptoms in adult patients with active ankylosing spondylitis

certolizumab pegol
200 mg/mL pre-filled syringe

24/11/2015

First Review Completed

Cimzia
To be used alone or in combination with methotrexate for reducing signs and symptoms and inhibiting the progression of structural damage as assessed by X-ray, in adult patients with moderately to severely active Psoriatic Arthritis who have failed one or more DMARDs

certolizumab pegol
200 mg/mL pre-filled syringe

30/11/2015

First Review Completed

Cimzia
In combination with methotrexate (MTX) in adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia alone or in combination with methotrexate (MTX) is indicated in adult patients with moderately to severely active psoriatic arthritis (PsA) who have failed one or more disease-modifying anti-rheumatic drugs (DMARDs). Cimzia is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

certolizumab pegol
200 mg/mL pre-filled pen

05/04/2018

First Review Completed

Cimzia
The treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy.

certolizumab pegol
200 mg/mL SC single use pre-filled syringe and pre-filled autoinjector

26/08/2019

Active

Cinqair
As add-on maintenance treatment of adult patients with severe eosinophilic asthma who are inadequately controlled with medium-to-high-dose inhaled corticosteroids and an additional asthma controller(s) (e.g., LABA) and have a blood eosinophil count of ≥400 cells/µL at initiation of the treatment

reslizumab
100 mg/10 mL solution for infusion

08/03/2017

Active

Cipralex Meltz
For the symptomatic relief of Major Depressive Disorder (MDD)

escitalopram
10 mg and 20 mg orally disintegrating tablet

16/01/2014

First Review Completed

Ciprodex
Antibacterial - Corticosteroid

ciprofloxacin HCl & dexamethasone
0.3 % / 0.1% otic suspension

30/05/2012

First Review Completed

Clindoxyl ADV Gel
Topical treatment of moderate acne vulgaris characterized by the presence of comedones, papules and pustules

clindamycin / benzoyl peroxide
1 % / 3 % topical gel

21/01/2015

First Review Completed

Clinoleic 20%
For parenteral nutrition in adults when oral or enteral nutrition is not possible, insufficient, or contraindicated.

refined olive oil and refined soybean oil
16 %/4 % w/w lipid emulsion for IV nutrition

08/11/2019

Active

Combivent Respimat
For treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD)

ipratropium/salbutamol FDC
20 mcg/100 mcg inhalation solution

04/08/2015

Reconsideration Completed

Complera
For use alone as a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment – naïve adults

emtricitabine/rilpivirine/tenofovir disoproxil fumarate
200 mg/25 mg/300 mg FC tablet

21/09/2012

First Review Completed

Constella
Treatment of irritable bowel syndrome with constipation (IBS-C) in adults

linaclotide
290 mcg capsule

29/02/2016

First Review Completed

Contour Next Blood Glucose Test Strips
To measure the concentration of glucose in the blood

FAD glucose dehydrogenase

19/09/2013

First Review Completed

Contrave
Indication: indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
– 30 kg/m2 or greater (obese) or
– 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., controlled hypertension, type 2 diabetes mellitus, or dyslipidemia).

naltrexone HCl & bupropion HCl
8 mg & 90 mg ER tablet

03/04/2020

Active

Calquence
Monotherapy for patients with chronic lymphocytic leukemia (CLL) who have received at least one therapy.

acalabrutinib
100 mg capsule

03/12/2021

First Review Completed

Calquence
In combination with obinutuzumab or as monotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia.

acalabrutinib
100 mg capsule

03/12/2021

First Review Completed

Copaxone
Clinically Isolated Syndrome (CIS), after a first demyelinating event

glatiramer acetate
20 mg/1 mL pre-filled syringe

07/01/2011

First Review Completed

Copaxone
Treatment of ambulatory patients with Relapsing Remitting Multiple Sclerosis (RRMS): 1) To decrease the frequency of clinical exacerbations and 2) To reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans

glatiramer acetate
40 mg/mL subcutaneous injection

29/05/2018

Active

Cortiment MMX
For the induction of remission in patients with active, mild to moderate ulcerative colitis

budesonide
9 mg delayed and extended-release tablet

29/05/2017

Active

Corzyna
Add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists)

ranolazine
500 mg and 1000 mg extended-release tablets

04/03/2021

Active

Cabometyx
For advanced hepatocellular carcinoma (HCC) in patients who have previously been treated

cabozatinib
20 mg, 40 mg and 60 mg tablet

29/12/2021

First Review Completed

Cabometyx
For the treatment of adult patients with advanced renal cell carcinoma who have received prior therapy

cabozatinib
20 mg, 40 mg and 60 mg tablet

29/12/2021

First Review Completed

Cosentyx
Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy

secukinumab
150 mg/mL subcutaneous solution

30/08/2016

First Review Completed

Cosentyx
Psoriatic arthritis

secukinumab
150 mg/mL subcutaneous solution

05/04/2018

First Review Completed

Cosentyx
For the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy

secukinumab
150 mg/mL subcutaneous solution

28/03/2018

First Review Completed

Cosentyx
For the treatment of adult patients with ankylosing spondylitis (AS)

secukinumab
150 mg/mL subcutaneous solution

06/11/2020

Active

Cotellic
For the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation

cobimetinib
20 mg tablet

05/04/2018

First Review Completed

Coversyl Plus HD
Hypertension

perindopril erbumine/indapamide
8 mg/2.5 mg tablet

29/04/2010

First Review Completed

Creon Minimicrospheres 35
Pediatric and adult patients for the treatment of pancreatic exocrine insufficiency (PEI) attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy)

lipase/amylase/protease
35000/35700/2240 units, capsule

29/10/2021

First Review Completed

Cresemba
For the treatment of invasive aspergillosis and invasive mucormycosis according to clinical criteria

isavuconazole sulfate
100 mg capsule

04/03/2020

First Review Completed

Crysvita
For the treatment of X-linked hypophosphatemia (XLH) according to clinical criteria.

burosumab
10 mg/mL, 20 mg/mL and 30 mg/mL solution for subcutaneous injection

21/12/2021

First Review Completed

Cubicin
For the treatment of patients with cSSSI or SAB/SARIE MRSA infections

daptomycin
500 mg/10 mL injection

04/01/2012

First Review Completed

Cubicin
For the treatment of patients with Staphylococcus aureus (SA) bloodstream infection including right-sided SA infective endocarditis infection caused by MRSA who are intolerant, contraindicated or have failed to respond adequately to vancomycin

daptomycin
500 mg/10 mL injection

24/11/2015

First Review Completed

Cyramza
As a single agent or in combination with paclitaxel for the treatment of patients with advanced advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma, with disease progression on or after prior platinum and fluoropyrimidine chemotherapy

ramucirumab
10 mg/mL solution

06/06/2017

First Review Completed

Cystadrops
The treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.

cysteamine HCl
0.37 % w/w ophthalmic solution

07/06/2019

Active

Camzyos
For the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) Class II-III in adult patients

MAVACAMTEN
2.5 mg, 5 mg, 10 mg and 15 mg capsule

12/12/2022

Active

Daklinza
Treatment of chronic Hepatitis C infections in combination with other agents

dalatasvir
30 mg and 60 mg tablet

15/06/2018

First Review Completed

Darzalex
For the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are refractory to both a PI and an IMiD

daratumumab
100 mg/5 mL and 400 mg/20 mL solution for infusion

21/03/2017

Active

Darzalex
Indicated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

daratumumab
100 mg/5 mL and 400 mg/20 mL solution for infusion

21/03/2019

First Review Completed

Darzalex
Darzalex (daratumumab) in combination with bortezomib, melphalan and prednisone for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant

daratumumab
100 mg/5 mL and 400 mg/20 mL solution for infusion

01/04/2019

Active

Darzalex
In combination with lenalidomide and dexamethasone, for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

daratumumab
100 mg/5 mL and 400 mg/20 mL solution for infusion

06/11/2019

Active

Darzalex SC
– In combination with lenalidomide and dexamethasone (DRd), or with bortezomib, melphalan and prednisone (DVMP), for the treatment of patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT)
– In combination with lenalidomide and dexamethasone (DRd), or bortezomib and dexamethasone (DVd), for the treatment of patients with multiple myeloma who have received at least one prior therapy (RRMM).

daratumumab
120 mg/mL subcutaneous injection (new dosage form)

27/11/2020

Active

Daurismo
In combination with low-dose cytarabine, for the treatment of newly diagnosed and previously untreated acute myeloid leukemia (AML) in adult patients, who are age ≥75 years or who are not eligible to receive intensive induction chemotherapy.

glasdegib maleate
25 mg tablet

18/12/2020

Active

Emgality
For the preventative treatment of migraine in adults who have at least four migraine days per month and have experienced an inadequate response, intolerance, or contraindication to at least two prophylactic migraine medications

GALCANEZUMAB
120 mg/mL SC solution, single use prefilled syringe and single use prefilled pen

01/12/2022

First Review Completed

Daxas
Maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis

roflumilast
500 mcg film-coated tablet

17/05/2012

Reconsideration Completed

DDAVP MELT
Central diabetes insipidus and primary nocturnal enuresis

desmopressin acetate
240 mcg tablet

30/06/2010

First Review Completed

Delstrigo
Indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults without past or present evidence of viral resistance to doravirine, lamivudine, or tenofovir.

doravirine/lamivudine/tenofovir disoproxil fumarate
100 mg/300 mg/300 mg tablet

31/10/2019

First Review Completed

Descovy
In combination with other antiretrovirals (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 12 years of age and older

emtrictabine/tenofovir alafenamide
200 mg/10 mg and 200 mg/25 mg tablet

31/03/2017

Active

Dexedrine Spansule SRC
For treatment of attention deficit hyperactivity disorder and narcolepsy

dextroamphetamine sulfate
10 mg and 15 mg sustained-release capsule

27/06/2013

First Review Completed

Diacomit
In conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet syndrome)

stiripentol
250 mg and 500 mg capsule

30/07/2015

First Review Completed

Diamicron MR
Diabetes mellitus

gliclazide
60 mg MR tablet

26/07/2011

First Review Completed

Dificid
For the treatment of Clostridium difficile infection (CDI) in adults ≥ 18 years of age

fidaxomicin
200 mg FC tablet

16/01/2014

First Review Completed

Diovan-HCT
Hypertension

valsartan/hydrochlorothiazide
320 mg/12.5 mg and 320 mg/25 mg tablet

25/02/2009

First Review Completed

Dovato
For the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 40 kg.

dolutegravir & lamivudine
50 mg & 300 mg tablet

31/01/2020

First Review Completed

Dovobet Gel
Mild to moderate plaque psoriasis vulgaris on the body in patients 18 years and older for up to 8 weeks

calcipotriol & betamethasone dipropionate
50 mcg/g / 0.5 mg/g topical gel

27/05/2014

First Review Completed

Doptelet
For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

AVATROMBOPAG
20 mg tablet

14/12/2022

Active

Duaklir Genuair
Long-term maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

formoterol fumarate dehydrate & aclidinium bromide
12 µG/ACT & 400 µG/ACT inhalation powder

29/02/2016

First Review Completed

Duobrii
For improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis.

halobetasol propionate and tazarotene
0.01 % & 0.045% lotion

31/01/2022

First Review Completed

Duodopa
Parkinson’s disease

levodopa/carbidopa
20 mg/mL and 5 mg/mL gel

23/06/2014

Reconsideration Completed

DuoTrav
Ocular hypertension and open-angle glaucoma

travoprost/timolol maleate
0.004 % and 0.5 % ophthalmic solution

03/11/2009

First Review Completed

Dupixent
For the treatment of atopic dermatitis for patients who meet clinical criteria.

dupilumab
150 mg/mL & 200 mg/1.14 mL solution for subcutaneous injection

06/05/2021

First Review Completed

Dupixent
As an add-on maintenance treatment in patients aged 12 years and older with severe asthma with a type 2/eosinophilic phenotype or oral corticosteroid dependent asthma.

dupilumab
300 mg prefilled syringe and 200 mg prefilled syringe, solution for subcutaneous injection

21/01/2021

Active

Dupixent
For the treatment of patients aged 12 years and older with moderate-to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.

dupilumab
150 mg/mL & 200 mg/1.14mL solution for subcutaneous injection

24/04/2020

Active

Dupixent
For the treatment of patients aged 12 years and older with moderate-to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

dupilumab
New Format: 150 mg/1mL prefilled pen, solution for subcutaneous injection in 2mL prefilled pen

03/12/2021

First Review Completed

Dupixent
For the treatment of atopic dermatitis for patients who meet clinical criteria

dupilumab
150 mg/mL solution for subcutaneous injection

06/05/2021

First Review Completed

Dupixent
For the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who meet specified clinical criteria

DUPILUMAB
200 mg/1.14 mL (175 mg/mL) pre-filled pen

01/12/2022

First Review Completed

Duragesic Mat
Opioid analgesic

fentanyl
25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr transdermal patch

29/04/2010

First Review Completed

Dayvigo
For the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.

LEMBOREXANT
5 mg and 10 mg tablets

16/08/2022

Active

Dymista
Symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptomsin adults and adolescents aged 12 years and older for whom monotherapy with either antihistamines or intranasal corticosteroids is not considered sufficient

fluticasone propionate & azelastine HCl
50 mcg & 137 mcg (per actuation) spray, metered dose (nasal)

24/11/2015

First Review Completed

Dysport Therapeutic
For the symptomatic treatment of focal spasticity affecting the upper limbs in adults.

abobotulinumtoxinA
300 units/vial and 500 units/vial IM lyophilized powder for solution for injection

20/09/2018

First Review Completed

Dysport Therapeutic
To reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults.

abobotulinumtoxinA
300 units/vial and 500 units/vial IM lyophilized powder for solution for injection

20/09/2018

First Review Completed

Dysport Therapeutic
For the treatment of lower limb spasticity in pediatric patients 2 years of age and older.

abobotulinumtoxinA
300 and 500 units per vial

20/09/2018

First Review Completed

Edarbi
For the treatment of mild to moderate essential hypertension

azilsartan medoxomil
40 mg and 80 mg tablet

02/05/2014

First Review Completed

Edarbyclor
As initial therapy in patients with severe essential hypertension for whom the benefit of a prompt blood pressure reduction exceeds the risk of initiating combination therapy

azilsartan medoxomil/chlorthalidone
40 mg/12.5 mg, 80 mg/12.5 mg and 40 mg/25 mg tablet

25/03/2014

First Review Completed

Edurant
Treatment of HIV-1 infection in antiretroviral treatment-naïve adult patients

rilpivirine hydrochloride
25 mg tablet

19/07/2012

First Review Completed

Effient, Pre-Notice of Compliance
Prevention of atherothrombotic events in patients with acute coronary syndrome (ACS)

prasugrel hydrochloride
10 mg tablet

19/10/2011

Reconsideration Completed

Egrifta
The treatment of excess visceral adipose tissue (VAT) in treatment experienced adult HIV infected patients with lipodystrophy

tesamorelin
1 mg/vial powder for solution

13/06/2016

Active

Elelyso
Long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease; may also be used in pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease, and for the haematological manifestations in pediatric patients with a confirmed diagnosis of Type 3 Gaucher disease.

taliglucerase alfa
200 units (per vial) powder for solution (intravenous)

22/03/2016

First Review Completed

Eliquis
Treatment of venous thromboembolic (VTE) events (deep vein thrombosis [DVT], pulmonary embolism [PE]) and prevention of recurrent DVT and PE

apixaban
2.5 mg and 5 mg FC tablet

24/11/2015

First Review Completed

Eliquis
For the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective knee or hip replacement surgery

apixaban
2.5 mg FC tablet

24/11/2015

First Review Completed

Eliquis
Prevention of stroke and systemic embolism in patients with atrial fibrillation

apixaban
2.5 mg and 5 mg tablet

22/08/2013

First Review Completed

Eloxatin
Metastatic colorectal cancer

oxaliplatin
50 mg/10 mL, 100 mg/20 mL and 200 mg/40 mL solution

05/07/2011

First Review Completed

Eloxatin
As part of the FOLFIRINOX regimen for the treatment of metastatic pancreatic cancer

oxaliplatin
50 mg/10 mL, 100 mg/20 mL and 200 mg/40 mL solution

04/01/2012

First Review Completed

Elonox, Elonox HP
Anticoagulant/ Antithrombotic Agent

ENOXAPARIN SODIUM
30 mg /0.3 mL, 40 mg /0.4 mL, 60 mg /0.6 mL, 80 mg /0.8 mL, 100 mg /1.0 mL, 120 mg /0.8 mL & 150 mg /1.0 mL SC solution

05/12/2022

Active

Emerade
For the emergency treatment of anaphylactic reactions in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

epinephrine
0.15 mg, 0.3 mg and 0.5 mg solution for injection in pre-filled pen

04/10/2019

Active

Enbrel SureClick Auto Injector
Plaque psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, juvenile idiopathic arthritis

etanercept
50 mg/mL pre-filled syringe

19/10/2011

First Review Completed

Enerzair Breezhaler
For once-daily maintenance treatment of asthma in patients aged 12 years and older with reversible obstructive airways disease.

indacaterol acetate/glycopyrronium bromide/mometasone
150 mcg/50 mcg/80 mcg capsule for inhalation

28/02/2022

First Review Completed

Enspryng
As monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients who are anti-aquaporin 4 (AQP4) seropositive

SATRALIZUMAB
120 mg/mL SC solution

22/12/2020

Active

Enstilar
Topical treatment of psoriasis vulgaris in adults for up to 4 weeks

betamethasone (as diproprionate) & calcipotriol (as monohydrate)
0.5 mg/g & 50 mcg/g aerosol foam (topical)

24/10/2018

First Review Completed

Entresto
Addition to the existing criteria: Initiation of sacubitril/valsartan may be considered in patients stabilized from an ADHF hospitalization without prior exposure to angiotensinconverting enzyme inhibitor or angiotensin II receptor blocker.

SACUBITRIL & VALSARTAN
24.3 mg/ 25.7 mg, 48.6 mg/ 51.4 mg and 97.2 mg/ 102.8 mg tablet

18/12/2020

Active

Entresto
For the treatment of heart failure with reduced ejection fraction (HFrEF) in patients with NYHA Class II or III, to reduce the incidence of cardiovascular death and heart failure hospitalisation

sacubitril & valsartan
24.3 mg/25.7 mg, 48.6 mg/51.4 mg, 97.2 mg/102.8 mg FC tablet

20/04/2017

First Review Completed

Enhertu
For the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy.

TRASTUZUMAB DERUXTECAN
100 mg/vial IV, powder for concentrate for solution for infusion

08/08/2022

Active

Entyvio
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a TNFα antagonist.

vedolizumab
108 mg / 0.68 mL prefilled pen and 108 mg / 0.68 mL prefilled syringe

08/05/2020

Active

Entyvio
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a TNFα antagonist

vedolizumab
300 mg/vial powder for solution

20/04/2017

First Review Completed

Entyvio
For patients with moderately to severely active Crohn’s disease (CD)

vedolizumab
300 mg/vial powder for solution

20/04/2017

First Review Completed

Entyvio
New subcutaneous presentation: For the treatment of adults with moderately to severely active CD.

vedolizumab
108 mg / 0.68 mL SC solution (prefilled pen and prefilled syringe)

11/01/2022

First Review Completed

Envarsus PA
For the prophylaxis of organ rejection in allogenic kidney or liver transplant adult patients in combination with other immunosuppressants.

tacrolimus
0.75 mg, 1 mg, and 4 mg prolonged-release tablets

30/09/2020

First Review Completed

Epclusa
For the treatment of chronic hepatitis C virus (HCV) infection

sofosbuvir & velpatasvir
400 mg & 100 mg tablet

13/03/2017

First Review Completed

Epuris
Severe Nodular and/or Inflammatory Acne, Acne Conglobata and Recalcitrant Acne

isotretinoin
10 mg, 20mg, 30mg and 40mg capsule

20/02/2014

First Review Completed

Erbitux
Initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck

cetuximab
2 mg/mL injection

17/04/2012

First Review Completed

Erbitux
EGFR-expressing metastatic colorectal carcinoma in patients who are refractory or intolerant to other irinotecan-based regimens

cetuximab
2 mg/mL injection

16/10/2009

First Review Completed

Erelzi
For reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in adult patients with psoriatic arthritis (PsA). ERELZI can be used in combination with methotrexate in adult patients who do not respond adequately to methotrexate alone.

etanercept
50 mg/mL SensoReady Pen, 50 mg/mL prefilled syringe, and 25 mg/0.5mL prefilled syringe SC solution for injection

01/04/2019

First Review Completed

Erelzi
For treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy” and “treatment of pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy. Data on safety and efficacy are limited in the age group 4 to 6 years.

etanercept
50 mg/mL solution for injection in a prefilled syringe and prefilled autoinjector, 25 mg/0.5 mL solution for injection in a prefilled syringe

30/092020

First Review Completed

Erelzi
For: - treatment of moderately to severely active rheumatoid arthritis (RA) in adults. Treatment is effective in reducing the signs and symptoms of RA, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function. Erelzi can be initiated in combination with methotrexate (MTX) in adult patients or used alone. - reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Erelzi has not been studied in children less than 4 years of age. - reducing signs and symptoms of active ankylosing spondylitis (AS).

etanercept
50 mg/ mL solution injection

22/03/2018

First Review Completed

Eretzi
Treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Treatment of pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy. Data on safety and efficacy are limited in the age group 4 to 6 years.

etanercept
50 mg/mL solution for injection in a prefilled syringe and prefilled autoinjector, 25 mg/0.5 mL solution for injection in a prefilled syringe

30/09/2020

First Review Completed

Erivedge
For the treatment of adult patients with metastatic basal cell carcinoma or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy

vismodegib
150 mg capsule

22/04/2014

First Review Completed

Erleada
For the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC)

apalutamide
60 mg tablet

31/08/2020

First Review Completed

Erleada
For the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC)

apalutamide
60 mg tablet

18/11/2021

First Review Completed

Esbriet
For the treatment of mild to moderate idiopathic pulmonary fibrosis in adults

pirfenidone
267 mg capsule

21/08/2014

First Review Completed

Esbriet
For the treatment of mild to moderate idiopathic pulmonary fibrosis in adults

pirfenidone
267 mg and 801 mg tablet

05/04/2018

First Review Completed

Esbriet
For the treatment of idiopathic pulmonary fibrosis (IPF) in adults

pirfenidone
267 mg and 801 mg tablet

06/20/2018

First Review Completed

Eucrisa
For topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.

crisaborole
2 % Ointment for topical use

16/11/2018

Active

Evenity
The treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture

romosozumab
90 mg /mL (105 mg/1.17 mL)

08/04/2021

Active

Evrysdi
For the treatment of spinal muscular atrophy according to clinical criteria.

risdiplam
0.75 mg/mL powder for solution

28/03/2022

First Review Completed

Entuzity KwikPen
To improve glycemic control in adults and children with diabetes mellitus requiring more than 200 units of insulin per day.

INSULIN INJECTION HUMAN BIOSYNTHETIC
500 units/mL solution for injection, prefilled pen

29/04/2022

First Review Completed

Extavia
Multiple sclerosis

interferon beta-1b
0.3 mg/vial powder for solution

21/03/2011

First Review Completed

Eylea
For the treatment of neovascular (wet) age-related macular degeneration (AMD)

aflibercept
40 mg/mL/solution for intravitreal injection

04/08/2015

First Review Completed

Eylea
For the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion

aflibercept
40 mg/mL/solution for intravitreal injection

04/08/2015

First Review Completed

Eylea
Treatment of diabetic macular edema

aflibercept
40 mg/mL/solution for intravitreal injection

04/08/2015

First Review Completed

Eylea
The treatment of visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO)

aflibercept
2 mg solution for intravitreal injection

31/03/2017

First Review Completed

Eylea
Indication:
– the treatment of neovascular (wet) age-related macular degeneration (AMD)
– the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO)
– the treatment of visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO)
– the treatment of diabetic macular edema (DME).

aflibercept
40 mg/mL solution for intravitreal injection

31/05/2021

First Review Completed

Fampyra
For the symptomatic improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (EDSS 3.5-7)

fampridine
10 mg SR tablet

20/09/2013

Second Review Completed

Fampyra
Symptomatic improvement of walking in adult patients with multiple sclerosis with walking disability

fampridine
10 mg SR tablet

30/07/2015

File Closed

Fasenra
For add-on maintenance treatment of adult patients with severe eosinophilic asthma who are inadequately controlled with high-dose ICS and one or more additional controller(s) (e.g. LABA), if one of the following clinical criteria are met 1.Blood eosinophil count ≥300 cells/µLand have experienced twoor more clinically significant asthma exacerbationsn the past 12 months, or 2.Blood eosinophil count ≥150cells/µLand are treated chronically with OCS.

benralizumab
30 mg/mL solution for subcutaneous injection

25/07/2018

Active

Fasenra Pen
As an add-on maintenance treatment of adult patients with severe eosinophilic asthma.

benralizumab
30 mg/mL SC solution - New Presentation: Single Use Prefilled Auto-Injector

12/04/2021

First Review Completed

Faslodex
Locally advanced or metastatic breast cancer in postmenopausal women

fulvestrant
50 mg/mL injection

10/07/2009

First Review Completed

Faslodex
For the hormonal treatment of non-visceral locally advanced or metastatic HER2- breast cancer in postmenopausal women, regardless of age, who have not been previously treated with endocrine therapy

fulvestrant
50 mg/mL intramuscular solution injection

01/03/2018

Active

Fentora
For the treatment of breakthrough pain (transient, incremental pain over and above baseline) in patients with advanced cancer

fentanyl citrate
100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg tablet

06/07/2016

File Closed

Fentora
For the management of breakthrough pain in advanced cancer patients 18 years of age or older with the underlying pain adequately managed using a continuous opioid therapy (persistent baseline cancer pain)

fentanyl citrate
100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg tablet

22/03/2017

Active

Ferriprox
For the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate

deferiprone
1000 mg tablet

28/03/2017

First Review Completed

Ferriprox
For the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate

deferiprone
100 mg/mL oral solution

15/06/2018

First Review Completed

Ferriprox
For the treatment of patients with transfusional iron overload due to sickle cell disease or other anemias

deferiprone
100 mg/mL solution (oral) & 1000 mg tablet

16/09/2022

Active

Fiasp
For the treatment of adult patients with diabetes mellitus who require mealtime insulin for the control of hyperglycemia

insulin aspart
100 U/mL vial, 100 U/mL penfill cartridge and 100 U/mL pre-filled pen

28/05/2018

Active

Fibristal
Treatment of moderate to severe signs and symptoms of uterine fibroids in adult women

ulipristal acetate
5 mg tablet

29/02/2016

First Review Completed

Fibristal
Treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age, who are eligible for surgery. The duration of treatment is two courses, with each course limited to 3 months

ulipristal acetate
5 mg tablet

15/06/2018

First Review Completed

Finacea
Topical treatment of mild to moderate rosacea

azelaic acid
15% topical gel

08/09/2011

First Review Completed

Firazyr
For the treatment of acute attacks of hereditary angioedema (HAE) in adults with C1-esterase inhibitor deficiency

icatibant acetate
10 mg/mL SC solution

24/11/2015

First Review Completed

Firmagon
Advanced hormone-dependent prostate cancer

degarelix acetate
80 mg/vial and 120 mg/vial powder for solution

21/03/2011

First Review Completed

Fluanxol Depot
Schizophrenia

flupenthixol decanoate
20 mg/mL solution in 1mL ampoule and 100 mg/mL solution in 1mL ampoule

27/05/2009

First Review Completed

Fludara
For the treatment of patients with previously untreated CLL when used in combination with rituximab

fludarabine
10 mg tablet

26/07/2011

First Review Completed

Folotyn
For the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) according to clinical criteria.

pralatrexate
20 mg/mL IV solution

17/07/2020

First Review Completed

Foquest
Treatment of attention deficit/hyperactivity disorder (ADHD) in adults (>= 18 years of age)

 

METHYLPHENIDATE HYDROCHLORIDE
25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg, and 100 mg CR capsule

03/05/2019

File Closed

Foquest
For the treatment of attention deficit hyperactivity disorder in patients aged 6 years and older

 

METHYLPHENIDATE HYDROCHLORIDE 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg, 100 mg CR capsule

23/11/2022

Active

Fora Test N' Go Test Strip
To measure the concentration of glucose in the blood

GDH-FAD glucose dehydrogenase

15/06/2018

First Review Completed

Forteo
Osteoporosis (glucocorticoid – induced)

teriparatide
250 mcg/mL injection

27/05/2014

Reconsideration Completed

Forxiga
For use in patients with type 2 diabetes mellitus to improve glycemic control

dapagliflozin
5 mg and 10 mg tablet

15/06/2018

First Review Completed

Forxiga
For the treatment of patients with type 2 diabetes mellitus to improve glycemic control when added on to metformin and a sulfonylurea for patients with inadequate glycemic control on metformin and a sulfonylurea and for whom insulin is not an option

dapagliflozin
5 mg and 10 mg tablet

15/06/2018

First Review Completed

Forxiga
In adults, as an adjunct to standard of care therapy, for the treatment of heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure and urgent heart failure visit.

dapagliflozin
5 mg and 10 mg tablet

17/12/2021

First Review Completed

Forxiga
For use in patients with type 2 diabetes mellitus to improve glycemic control

dapagliflozin
5 mg and 10 mg tablet

15/06/2018

First Review Completed

Forxiga
For the treatment of patients with type 2 diabetes mellitus to improve glycemic control when added on to metformin and a sulfonylurea for patients with inadequate glycemic control on metformin and a sulfonylurea and for whom insulin is not an option

dapagliflozin
5 mg and 10 mg tablet

15/06/2018

First Review Completed

Forxiga
In adults, as an adjunct to standard of care therapy, for the treatment of heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure and urgent heart failure visit.

dapagliflozin
5 mg and 10 mg tablet

17/12/2021

First Review Completed

Fosavance
Osteoporosis in postmenopausal women and osteoporosis in men

alendronate sodium/cholecalciferol
70 mg/140 µg tablet

16/06/2009

First Review Completed

Fragmin
Anticoagulation

dalteparin sodium
7500IU/0.3 mL pre-filled safety syringe

17/02/2012

First Review Completed

Fragmin
Anticoagulation

dalteparin sodium
2,500 IU/mL solution for injection

24/11/2015

First Review Completed

Fragmin
Thromboprophylaxis in conjunction with surgery; Treatment of acute deep venous thrombosis; Unstable coronary artery disease (UCAD), i.e., unstable angina and non-Q-wave myocardial infarction; Prevention of clotting in the extracorporeal system during hemodialysis and hemofiltration in connection with acute renal failure or chronic renal insufficiency; Extended treatment of symptomatic venous thromboembolism to prevent recurrence of venous thromboembolism in patients with cancer; Reduction of deep vein thrombosis (DVT) in hospitalized patients with severely restricted mobility during acute illness.

dalteparin sodium
16,500 IU / 0.66 mL prefilled syringe

26/02/2021

First Review Completed

Fragmin 3500 IU (Anti-Factor XA)/0.28mL
For anticoagulation/ antithrombotic therapy

dalteparin sodium
3500 unit/0.28mL single dose prefilled syringes

26/06/2018

First Review Completed

FreeStyle Libre 2 Flash Glucose Monitoring System
For measuring interstitial fluid glucose levels in people aged 4 years and
older with diabetes mellitus

30/11/2021

First Review Completed

FreeStyle Precision Blood Glucose Test Strips
To measure the concentration of glucose in the blood

glucose dehydrogenase

21/11/2014

First Review Completed

Fulphila
To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti- neoplastic drugs.

pegfilgrastim
6 mg (10 mg/mL) SC solution for injection

08/11/2019

Active

Fycompa
As adjunctive therapy in the management of partial-onset seizures, in adult patients with epilepsy who are not satisfactorily controlled with conventional therapy

perampanel
2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablet

20/02/2014

First Review Completed

Fycompa
As an adjunctive therapy for the management of primary generalized tonic-clonic seizures in adults

perampanel
2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablet

29/07/2016

Active

Givlaari
For the treatment of acute hepatic porphyria (AHP) in adults.

GIVOSIRAN
189 mg/ mL SC Solution

01/12/2021

Active

Galafold
For long-term treatment of adult and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation.

migalastat HCl
123 mg capsule

13/05/2019

First Review Completed

Galexos
Treatment of chronic hepatitis C

simeprevir sodium
150 mg capsule

29/09/2014

First Review Completed

Gazyva
In combination with chlorambucil for previously untreated chronic lymphocytic leukaemia where fludarabine-based therapy is considered inappropriate

obinutuzumab
25 mg/mL IV solution

04/08/2015

First Review Completed

Gazyva
In combination with chemotherapy for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab containing regimen

obinutuzumab
25 mg/mL IV solution

22/11/2018

First Review Completed

Gazyva
GAZYVA, in combination with chemotherapy followed by GAZYVA monotherapy, for the treatment of patients with previously untreated follicular lymphoma.

obinutuzumab
25 mg/mL Concentrate for Solution for Infusion

06/05/2022

First Review Completed

GE200 Glucose Test Strips
To measure the concentration of glucose in the blood

FAD-Glucose Dehygrogenase (FAD-GDH)
N/A

24/06/2015

First Review Completed

Gelnique
For the treatment of overactive bladder

oxybutynin chloride
100 mg/g topical gel

23/04/2013

Reconsideration Completed

Genotropin GoQuick Genotropin MiniQuick
For replacement of endogenous growth hormone in adults with growth hormone deficiency

somatropin
5.3 mg and 12 mg pre-filled pen, GoQuick 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg and 2 mg pre-filled syringe, MiniQuick

21/08/2014

First Review Completed

Genotropin GoQuick Genotropin MiniQuick
The treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed

somatropin
5.3 mg and 12 mg pre-filled pen, GoQuick 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg and 2 mg pre-filled syringe, MiniQuick

21/08/2014

First Review Completed

Genotropin GoQuick Genotropin MiniQuick
The long-term treatment of children who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency (GHD))

somatropin
5.3 mg and 12 mg pre-filled pen, GoQuick 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg and 2 mg pre-filled syringe, MiniQuick

21/08/2014

First Review Completed

Genvoya
As a complete regimen for the treatment- naïve and virologically suppressed HIV-1 infected adults and pediatric patients 12 years of age and older (and weighing > 35 kg) and with no known mutations associated with resistance to the individual components of GENVOYA

elvitegravir & cobicistat & emtricitabine & tenofovir alafenamide
150 mg & 150 mg & 200 mg & 10 mg tablet

20/04/2017

First Review Completed

Gilenya, Post-Notice of Compliance
For the treatment of patients with the relapsing-remitting form of multiple sclerosis (MS)

fingolimod HCl
0.5 mg capsule

23/04/2013

First Review Completed

Giotrif
As monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor naïve patients with metastatic (including cytologically proven pleural effusion) adenocarcinoma of the lung with activating EGFR mutation(s)

afatinib dimaleate
20 mg, 30 mg and 40 mg tablet

21/08/2014

First Review Completed

Glatect
Treatment of ambulatory patients with relapsing remitting multiple sclerosis, including patients who have experienced a single demyelinating event and have lesions typical of multiple sclerosis on brain MRI: to decrease the frequency of clinical exacerbations; and to reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans.

glatiramer acetate
20 mg/mL pre-filled syringe for subcutaneous injection

20/09/2018

First Review Completed

Gleevec
Adjuvant treatment of gastrointestinal stromal tumors

imatinib mesylate
100 mg and 400 mg tablet

27/04/2012

Reconsideration Completed

Glucagen, Glucagen Hypokit
Treatment of severe hypoglycemic reaction

glucagon
1 mg/vial powder for solution

04/01/2012

First Review Completed

GlucoDr. Auto Test Strip
To measure the concentration of glucose in the blood

glucose dehydrogenase (FAD/GDH)

04/04/2018

First Review Completed

Grastek
For the treatment of signs and symptoms of grass allergy

standardized allergenic extract, Timothy grass (phleum pratense)
2800 BAU sublingual tablet

22/01/2015

First Review Completed

Grastofil
To reduce infections and/or the duration of neutropenia and related sequelae in the following patient groups: cancer patients receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia; cancer patients receiving myeloablative chemotherapy followed by bone marrow transplantation; patients with severe chronic neutropenia; and patients with HIV infection. Grastofil is also indicated for cancer patients undergoing peripheral blood progenitor cell collection and therapy

filgrastim
300 mcg/ 0.5 mL SC or IV Solution

28/03/2017

First Review Completed

Hadlima and Hadlima PushTouch
Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult Crohn’s Disease, Ulcerative Colitis, Hidradenitis Suppurativa, Plaque Psoriasis, Adult Uveitis, and Pediatric Uveitis.

adalimumab
40 mg in 0.8 mL solution for subcutaneous injection (prefilled syringe and autoinjector)

29/03/2021

First Review Completed

Halaven
For metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease

eribulin mesylate
0.5 mg/mL IV solution

17/01/2013

First Review Completed

Harvoni
For the treatment of chronic hepatitis C virus (CHC) genotype 1 infection in adults

ledipasvir/sofosbuvir
90 mg/400 mg tablet

30/06/2021

First Review Completed

Hemangiol
For the treatment of proliferating infantile hemangioma requiring systemic therapy: Life- or function-threatening hemangioma, Ulcerated hemangioma with pain and/or lack of response to simple wound care measures, and Hemangioma with a risk of permanent scarring or disfigurement

propranolol
3.75 mg/ mL oral solution

22/11/2019

First Review Completed

Heparin
Anticoagulant

heparin sodium
1000 U/mL & 10000 U/mL IV injection solution

25/06/2018

File Closed

Heparin Sodium Injection USP
For prophylaxis and treatment of venous thrombosis and its extension, prophylaxis and treatment of pulmonary embolism, prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation, prevention of clotting in arterial and heart surgery, prophylaxis and treatment of peripheral arterial embolism, anticoagulant use in blood transfusions, extracorporeal circulation and dialysis procedures and diagnosis and treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)

heparin sodium
1000 U/mL, 5000 U/mL and 10000 U/mL solution

26/11/2015

File Closed

Herceptin
Metastatic breast cancer beyond progression

trastuzumab
440 mg/ vial/ 20 mL/ vial powder for solution

17/01/2012

Reconsideration Completed

Herceptin SC
For use in the treatment of early and metastatic HER2-positive breast cancer patients.

trastuzumab
600 mg/5 mL solution for subcutaneous injection single dose vial

29/11/2018

Active

Herceptin, Pre-Notice of Compliance
Advanced gastric cancer

trastuzumab
440 mg/ vial/ 20mL/ vial powder for solution

17/01/2012

First Review Completed

Herzuma
For all eligible HER2 positive breast and gastric cancer (metastatic adenocarcinoma of the stomach or gastro-esophageal junction) patients

TRASTUZUMAB
440 mg/vial intravenous infusion

22/01/2020

First Review Completed

Herzuma

Early Breast Cancer (EBC)

Metastatic Breast Cancer (MBC)

Metastatic Gastric Cancer (MGC)

TRASTUZUMAB
440 mg/vial IV powder for solution, kit

22/01/2020

First Review Completed

Herzuma
HERZUMA can be used in combination with pertuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. For information on the use of HERZUMA in combination with pertuzumab and docetaxel, consult the Product Monograph for pertuzumab

TRASTUZUMAB
440 mg/vial IV powder for solution, kit and 150 mg/vial PWSO, IV

15/09/2022

First Review Completed

Holkira Pak
For the treatment of hepatitis C virus (HCV) genotype 1

ombitasvir/ paritaprevir/ ritonavir & dasabuvir
12.5mg/ 75mg/ 50mg & 250 mg FC tablet

30/07/2015

First Review Completed

Hulio
Biological Response Modifier

adalimumab
40 mg in 0.8 mL subcutaneous solution (prefilled syringe and prefilled pen)

29/03/2021

First Review Completed

Humalog Junior KwikPen
For treatment of diabetes

insulin lispro
100 units/mL solution for injection, prefilled pen

20/09/2019

First Review Completed

Humalog Kwikpen
For treatment of diabetes

insulin lispro
200 U/mL solution

25/06/2018

First Review Completed

Humalog KwikPen, Humalog Mix25 KwikPen, Humalog Mix50 KwikPen
Diabetes, Type 1 & 2

insulin lispro
100 U/mL, 25 %/ 75 % and 50 %/ 50 % prefilled pen

19/05/2011

First Review Completed

Humira
For treatment of fistulizing Crohn’s

adalimumab
40 mg/0.8 mL subcutaneous injection

05/07/2011

First Review Completed

Humira
In combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 to 17 years of age who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs)

adalimumab
40 mg/ 0.8 mL vial for pediatric use, 40 mg/ 0.8 mL pre-filled syringe and 40 mg/ 0.8 mL pre-filled pen

20/02/2014

First Review Completed

Humira
For ulcerative colitis

adalimumab
40 mg/ 0.8 mL subcutaneous solution

29/03/2016

File Closed

Humira
For the treatment of non-infections uveitis

adalimumab
40 mg/ 0.8 mL subcutaneous solution

26/11/2015

First Review Completed

Humira
For the treatment of active moderate to severe Hidradenitis Suppurativa in adult patients who have not responded to conventional therapy (including systemic antibiotics)

adalimumab
40 mg/0.8 mL subcutaneous solution

05/04/2018

First Review Completed

Humira
Treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids, azathiprine and/or 6-MP or who are intolerant to such therapies

adalimumab
40 mg/ 0.8 mL subcutaneous solution

25/06/2018

First Review Completed

Humira
Rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, psoriasis, uveitis

adalimumab
40 mg/ 0.4 mL solution (subcutaneous) pre-filled syringe and 40 mg/ 0.4 mL solution (subcutaneous) pre-filled pen (new strength)

25/06/2018

First Review Completed

Humira
For the treatment of pediatric patients in the following indications: Polyarticular juvenile idiopathic arthritis (JIA), Crohn’s disease, ulcerative colitis, non-infectious ocular inflammatory disease / uveitis.

adalimumab
20 mg/0.2 mL (100 mg/mL) SC solution for injection, (additional strength and format)

19/01/2021

First Review Completed

Hydromorph Contin
For the relief of severe chronic pain requiring the prolonged use of an oral opioid preparation

hydromorphone hydrochloride
4.5 mg and 9 mg CR capsule

18/01/2012

First Review Completed

Hymark Easy Plus Self Monitoring Blood Glucose Test Strip
To measure the concentration of glucose in the blood

glucose oxidase (aspergillus niger)
1.0 - 5.0 IU test strip

29/04/2011

First Review Completed

Hyrimoz
Expansion of the indications:
Pediatric Crohn’s Disease
- Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 13 to 17 years of age weighing ≥ 40 kg with severely active Crohn’s disease and/or who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumour necrosis factor alpha antagonist.
Hidradenitis Suppurativa
- Treatment of active moderate to severe hidradenitis suppurativa in adult and adolescent patients (12 to 17 years of age weighing ≥ 30 kg) who have not responded to conventional therapy (including systemic antibiotics).
Pediatric Uveitis
- Treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

adalimumab
40 mg/ 0.8 mL and 20 mg/0.4 mL SC solution (autoinjector pen and prefilled syringe)

31/05/2022

First Review Completed

Ibavyr
In combination with other agents for the treatment of chronic hepatitis C (CHC) in adults

ribavirin
400 mg and 600 mg tablet

05/05/2015

First Review Completed

Ibavyr
In combination with other agents for the treatment of chronic hepatitis C (CHC) in adults

ribavirin
200 mg tablet

06/01/2016

First Review Completed

Ibrance
For the treatment of patients with estrogen receptor (ER)– positive, human epidermal growth factor receptor 2 (HER 2)– negative, unresectable locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant according to clinical criteria

palbociclib
75 mg, 100 mg and 125 mg capsule

04/12/2020

First Review Completed

Ibrance
For the treatment of patients with estrogen receptor (ER) – positive, human epidermal growth factor receptor 2 (HER 2)– negative, unresectable locally advanced or metastatic breast cancer according to clinical criteria

palbociclib
75 mg, 100 mg, 125 mg tablets

04/12/2020

First Review Completed

Iclusig
Treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig is a BCR-ABL inhibitor that has activity against all clinically relevant BCR-ABL mutations, including the difficult-to-treat T315l mutation.

ponatinib HCl
15 mg and 45 mg tablet

25/06/2018

First Review Completed

Idacio
Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult Crohn’s Disease, Pediatric Crohn’s Disease, Ulcerative Colitis, Hidradenitis Suppurativa, Plaque Psoriasis, Adult Uveitis, Pediatric Uveitis.

ADALIMUMAB
40 mg / 0.8 mL (50 mg/mL) SC solution, pen injector

29/03/2021

First Review Completed

Idacio
Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult Crohn's Disease, Pediatric Crohn's Disease, Ulcerative Colitis, Hidradenitis Suppurativa, Plaque Psoriasis, Adult Uveitis, Pediatric Uveitis.

ADALIMUMAB
40 mg/ 0.8 mL (50 mg/mL) SC solution, prefilled syringe

29/10/2021

First Review Completed

Ideal Life Glucose Test Strip
To measure the concentration of glucose in the blood

glucose oxidase

25/06/2018

First Review Completed

Idhifa
For the treatment of adult patients with relapsed or refractory Acute Myeloid Leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.

enasidenib mesylate
50 mg 100 mg tablets

07/06/2019

Active

Ilaris
For the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older

canakinumab
150 mg powder for solution

25/08/2016

Active

Ilaris
For the ongoing management of Cryopyrin-Associated Periodic Syndromes

canakinumab
150 mg powder for solution

05/03/2018

Active

Iluvien
For the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

fluocinolone acetonide
0.19 mg Intravitreal implant

17/06/2019

Active

Intrarosa
For treatment of postmenopausal vulvovaginal atrophy

PRASTERONE
6.5 mg vaginal ovule

02/02/2022

Active

Inqovi
For treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups

DECITABINE / CEDAZURIDINE
35 mg/ 100 mg tablet

19/12/2022

First Review Completed

Inqovi
For treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups

DECITABINE / CEDAZURIDINE
35 mg/100 mg tablet

06/12/2022

Active

Imbruvica
Treatment of patients with chronic lymphocytic leukemia (CLL), including those with 17p deletion, who have received at least one prior therapy, or for the frontline treatment of patients with CLL with 17p deletion

ibrutinib
140 mg capsule

04/08/2015

First Review Completed

Imbruvica
For the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL)

ibrutinib
140 mg capsule

25/06/2018

First Review Completed

Imbruvica
Treatment of Waldenström’s Macroglobulinemia (WM)

ibrutinib
140 mg capsule

28/05/2018

Active

Imbruvica
For the treatment of patients with previously untreated Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) for whom fludarabine-based treatment is considered inappropriate

ibrutinib
140 mg capsule

13/03/2017

First Review Completed

Imfinzi
For the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) according to clinical criteria.

DURVALUMAB
50 mg/mL intravenous infusion

22/01/2020

First Review Completed

Imfinzi
In combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)

DURVALUMAB
50 mg/mL intravenous infusion

22/07/2022

First Review Completed

Imfinzi
Treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine-based chemotherapy

DURVALUMAB
50 mg/mL solution (IV infusion)

28/12/2022

Active

Incivek
Treatment of genotype 1 chronic hepatitis C

telaprevir
375 mg tablet

23/04/2014

Reconsideration Completed

Inclunox AND Inclunox HP
– The prophylaxis of thromboembolic disorders (deep vein thrombosis) in patients undergoing: – orthopedic surgery of the hip or knee. In addition, Inclunox is indicated in hospital or after hospital discharge for long-term prevention of venous thromboembolic diseases following hip replacement surgery. – high risk abdominal, gynecological, or urological surgeries; – colorectal surgery.
– The prophylaxis of deep vein thrombosis (DVT) in medical patients who are at moderate risk of DVT and who are bedridden due to moderate to severe acute cardiac insufficiency (NYHA Class III or IV heart failure), acute respiratory failure revealing or complicating chronic respiratory insufficiency not requiring ventilatory support and acute respiratory infections (excluding septic shock), who require short-term prophylaxis of deep vein thrombosis.
– The prevention of thrombus formation in the extra – corporeal circulation during hemodialysis.
– The treatment of deep vein thrombosis, with or without pulmonary embolism.
– The treatment of unstable angina or non-Q-wave myocardial infarction, concurrently with ASA.
– Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

enoxaparin sodium
30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL and 100 mg/mL AND 120 mg/0.8 mL and 150 mg/mL solution for injection

31/05/2021

First Review Completed

Ilumya
For the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

TILDRAKIZUMAB
100 mg/mL Injection Solution

28/02/2022

First Review Completed

Incruse Ellipta
For long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.

umeclidinium (as bromide)
62.5 mcg dry powder for oral inhalation

29/02/2016

First Review Completed

Inflectra
For treatment of Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Plaque Psoriasis

infliximab
100 mg/vial lyophilized powder

11/30/2016

First Review Completed

Imvexxy
For the treatment of postmenopausal moderate to severe dyspareunia, a
symptom of vulvar and vaginal atrophy.

ESTRADIOL HEMIHYDRAYTE
4 mcg and 10 mcg insert vagina

24/01/2022

Active

Inflectra
Crohn’s disease and ulcerative colitis

infliximab
100 mg/vial powder for solution

13/03/2017

First Review Completed

Inflectra
Pediatric Croihn's disease and pediatric ulcerative colitis
– For reducing signs and symptoms and for inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.
– For reducing signs and symptoms, inducing and maintaining clinical remission and inducing mucosal healing in pediatric patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/or an immunosuppressant).

infliximab
100 mg / vial lyophilized powder for solution (IV)

30/06/2020

Active

Inlyta
Treatment of patients with metastatic renal cell carcinoma of clear cell histology after failure of prior systemic therapy with either a cytokine or the VEGFR-TKI, sunitinib

axitinib
1 mg and 5 mg tablet

16/01/2014

First Review Completed

Innohep
Prevention of postoperative venous thromboembolism; Treatment of deep vein thrombosis and/or pulmonary embolism; Prevention of clotting in indwelling intravenous lines for haemodialysis

tinzaparin sodium
2,500 IU/0.25 mL prefilled syringe injection

20/08/2010

First Review Completed

Inrebic
For the treatment of splenomegaly and/or disease related symptoms in adult patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, including patients who have been previously exposed to ruxolitinib.

fedratinib
100 mg capsules

08/09/2022

First Review Completed

Inspiolto Respimat
For the long term, once daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema

tiotropium & olodaterol
2.5 mcg/2.5 mcg per actuation, inhalation solution

15/06/2018

First Review Completed

Inspra
Post myocardial infarction

eplerenone
25 mg and 50 mg tablet

29/04/2010

First Review Completed

Inspra
Heart failure, NYHA class ll

eplerenone
25 mg and 50 mg tablet

24/06/2015

First Review Completed

Intelence
In combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in treatment-experienced adult patients who have failed prior therapy and have HIV-1 strains resistant to multiple antiretroviral agents, including NNRTIs

etravirine
200 mg tablet

04/05/2012

First Review Completed

Intuniv XR
As monotherapy for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years

guanfacine hydrochloride
1 mg, 2 mg, 3 mg and 4 mg ER tablet

 

22/01/2015

First Review Completed

Intuniv XR
For the treatment of attention deficit hyperactivity disorder, according to specified criteria

guanfacine hydrochloride
1 mg, 2 mg, 3 mg and 4 mg ER tablet

31/01/2020

First Review Completed

Invega Sustenna
Schizophrenia

paliperidone palmitate
50 mg/0.5 mL, 75 mg/0.75 mL, 100 mg/1 mL and 150 mg/1.5 mL ER suspension

18/01/2012

First Review Completed

Invega Trinza
Treatment of schizophrenia in adult patients

paliperidone (supplied as paliperidone palmitate)
175 mg/0.875 mL, 263 mg/1.315 mL, 350 mg/1.75 mL, 525 mg/ 2.625 mL suspension (extended release; intramuscular) prefilled syringe

22/03/2018

First Review Completed

Invokamet
Type 2 diabetes

canagliflozin & metformin HCl
50 mg/500 mg, 50 mg/850 mg, 50 mg/1000 mg, 150 mg/500 mg, 150 mg/850 mg and 150 mg/1000 mg tablets

22/03/2017

Active

Invokana
As an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus

canagliflozin
100 mg and 300 mg tablet

04/08/2015

First Review Completed

Iressa
First-line treatment for locally advanced or metastatic non-small cell lung cancer

gefitinib
250 mg tablet

19/10/2011

Reconsideration Completed

Isentress
As part of a HIV treatment regimen for treatment-naive adult patients

raltegravir potassium
400 mg tablet

22/04/2014

First Review Completed

Istodax
For the treatment of patients with relapsed/refractory peripheral T-cell lymphoma

romidepsin
10 mg vial powder for intravenous solution

10/12/2015

First Review Completed

Izba
For the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

travoprost
0.003 % w/v ophthalmic aqueous solution

23/04/2019

First Review Completed

Jadenu
For patients with chronic iron overload in transfusion-related anemia due to beta-thalassemia or sickle cell disease and for the treatment of chronic iron overload in transfusion dependent anemia in those with low-risk myelodysplastic syndrome or other rare anemias (e.g. Diamond Blackfan) in patents who have a contraindication or severe intolerance to deferoxamine

deferasirox
90 mg, 180 mg and 360 mg FC tablet

20/04/2017

First Review Completed

Jakavi
The treatment of splenomegaly and/or its associated symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

RUXOLITINIB
10 mg tablet

04/08/2015

File Closed

Jakavi
The treatment of splenomegaly and/or its associated symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.

RUXOLITINIB
5 mg, 15 mg and 20 mg tablet

19/09/2013

First Review Completed

Jakavi
Control of hematocrit in adult patients with polycythemia vera (PV) resistant to or intolerant of a cytoreductive agent

RUXOLITINIB
5 mg, 10 mg, 15 mg, 20 mg tablet

25/06/2018

First Review Completed

Jakavi

For the treatment of steroid refractory or dependent acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

 

RUXOLITINIB
5 mg, 10 mg, 15 mg, 20 mg tablet

03/10/2022

Active

Jakavi

 For the treatment of chronic graft-versus-host disease (GVHD) in adults and pediatric patients aged 12 years and older who have inadequate response to corticosteroids or other systemic therapies.

RUXOLITINIB

5 mg, 10 mg, 15 mg and 20 mg tablets

03/10/2022

Active

Janumet
Diabetes, Type 2

sitagliptin/metformin hydrochloride
500 mg/50 mg, 850 mg/50 mg and 1000 mg/50 mg tablet

17/02/2012

First Review Completed

Janumet XR
Diabetes, Type 2

sitagliptin phosphate monohydrate and metformin hydrochloride
50 mg/1000 mg modified-release tablets

24/10/2014

First Review Completed

Janumet XR
Diabetes, Type 2

sitagliptin phosphate monohydrate and metformin hydrochloride
50 mg/500 mg and 100 mg/1000 mg ER tablet

28/03/2017

First Review Completed

Januvia
Diabetes, Type 2

sitagliptin phosphate monohydrate
25 mg and 50 mg tablet

19/09/2013

First Review Completed

Jardiance
To improve glycemic control in adult patients with type 2 diabetes mellitus

empagliflozin
10 mg and 25 mg tablet

30/05/2016

First Review Completed

Jardiance
Add-on combination in patients with established cardiovascular disease

empagliflozin
10 mg and 25 mg tablet

26/06/2018

First Review Completed

Jardiance
For the treatment of chronic heart failure in adults, as an adjunct to standard of care therapy

empagliflozin
10 mg tablet

08/07/2022

Active

Jaydess
For conception control

levonorgestrel
13.5 mg/unit intrauterine system

04/08/2015

First Review Completed

Jentadueto
To improve glycemic control in adult patients with type 2 diabetes mellitus

linagliptin/metformin hydrochloride
2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg tablet

25/03/2014

First Review Completed

Jetrea
The treatment of symptomatic vitreomacular adhesion (VMA)

ocriplasmin
2.5 mg/mL solution for intravitreal injection

12/12/2014

First Review Completed

Jevtana, Post-Notice of Compliance
For the treatment of patients with castration resistant metastatic prostate cancer

cabazitaxel
40 mg/mL intravenous solution

25/07/2012

First Review Completed

Jinarc
Slow the progression of kidney enlargement in patients with autosomal dominant polycystic kidney disease (ADPKD).

tolvaptan
45 mg+15 mg, 60 mg+30 mg, 90 mg+30 mg tablet

10/06/2016

First Review Completed

Jorveza
Induction of clinico-pathological remission in adults with eosinophilic esophagitis (EoE).

budesonide
1 mg orally disintegrating tablets

18/02/2020

Active

Jublia
The topical treatment of mild to moderate onychomycosis (tinea unguium) of toenails without lunula involvement due to Trichophyton rubrum and Trichophyton mentagrophytes in immunocompetent adult patients.

efinaconazole
10% w/w topical solution

01/04/2019

Active

Jemperli
Monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum containing regimen.

DOSTARLIMAB
500 mg/10 mL vial (50 mg/mL) IV solution

19/01/2022

Active

Kimmtrak
For the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (UM).

TEBENTAFUSP
100 mcg/0.5 mL IV solution

30/06/2022

Active

Juluca
For the treatment of human immunodeficiency virus (HIV-1) infection in adults who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per mL).

dolutegravir and rilpivirine
50 mg and 25 mg tablet

23/04/2019

First Review Completed

Jurnista
Moderate to severe chronic pain

hydromorphone hydrochloride
4 mg, 8 mg, 16 mg and 32 mg ER tablet

06/07/2011

Second Review Completed

Juxtapid
As an adjunct to a low-fat diet and other lipid-lowering drugs, with or without LDL apheresis, to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolemia (HoFH)

lomitapide (supplied as lomitapide mesylate)
5 mg, 10 mg, 20 mg capsule

30/11/2015

First Review Completed

Kadcyla
For the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab and taxane

trastuzumab emtansine
100 mg/160 mg IV powder for solution

27/05/2014

First Review Completed

Kadcyla
For the adjuvant treatment of patients with HER2-positive early breast cancer, who have residual disease according to clinical criteria

trastuzumab emtansine
20 mg/mL powder for solution (100 mg/vial and 160 mg/vial)

27/01/2021

First Review Completed

Kaletra
Human Immunodeficiency Virus (HIV) infection

lopinavir/ritonavir
100 mg/25 mg tablet

26/03/2009

First Review Completed

Kalydeco
For the treatment of cystic in patients age 6years and older according to clinical criteria

ivacaftor
150 mg tablet

20/12/2019

First Review Completed

Kalydeco
For the treatment of cystic fibrosis with mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene

ivacaftor
150 mg tablet

10/12/2015

First Review Completed

Kalydeco
Treatment of cystic fibrosis (CF) in patients age 18 years and older with an R117H mutation in the CFTR gene

ivacaftor
150 mg tablet

29/02/2016

Active

Kanjinti
For the treatment of Early Breast Cancer (EBC), Metastatic Breast Cancer (MBC) and Metastatic Gastric Cancer (MGC) of the stomach or gastro-esophageal junction according to clinical criteria

TRASTUZUMAB
420 mg/vial IV Powder for Solution, Kit

04/08/2020

First Review Completed

Kanjinti
KANJINTI can be used in combination with PERJETA (pertuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease

TRASTUZUMAB
420 mg/vial IV Powder for Solution, Kit

15/09/2022

First Review Completed

Kanjinti
Early Breast Cancer (EBC) KANJINTI (trastuzumab) is indicated for the treatment of patients with early stage breast cancer with ECOG 0 - 1 status, whose tumours overexpress HER2,
– Following surgery and after chemotherapy
– Following adjuvant chemotherapy consisting of doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel
– In combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. Metastatic Breast Cancer (MBC) KANJINTI is indicated for the treatment of patients with MBC whose tumours overexpress HER2. Metastatic Gastric Cancer (MGC) KANJINTI in combination with capecitabine or intravenous 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. KANJINTI should only be administered to patients with MGC whose tumours have HER2 overexpression as defined by IHC2+ confirmed by FISH+, or IHC 3+ as determined by an accurate and validated assay.

TRASTUZUMAB
150 mg intravenous, powder for solution, single dose vial

15/09/2022

First Review Completed

Kerendia
As an adjunct to standard of care therapy to delay progression of kidney disease and to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, non-fatal stroke) and hospitalization for heart failure in adults with chronic kidney disease and type 2 diabetes.

FINERENONE
10 mg and 20 mg tablets

05/12/2022

Active

Kanuma
For the treatment of lysosomal acid lipase (LAL) deficiency according to clinical criteria.

sebelipase alfa
2 mg/mL concentrate for solution for infusion

08/04/2021

First Review Completed

Kazano
To improve glycemic control in adult patients (≥ 18 years old) with type 2 diabetes mellitus

alogliptin (as alogliptin benzoate) / metformin hydrochloride
12.5 mg/ 500 mg, 12.5mg/ 850mg and 12.5mg/1000mg tablet

04/08/2015

First Review Completed

Kesimpta
For the treatment of Relapsing Remitting Multiple Sclerosis according to clinical criteria.

ofatumumab
20 mg / 0.4 mL SC solution for injection, pre-filled SensoReady Pen

25/03/2022

First Review Completed

Kevzara
For the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non- biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

sarilumab
150 mg and 200 mg solution for subcutaneous injection

31/05/2017

Active

Kevzara
For the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non- biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

sarilumab
New Format: 150 mg / 1.14 mL and 200 mg /1.14 mL prefilled pen

01/04/2019

Active

Keytruda
For the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor

PEMBROLIZUMAB
50 mg/vial powder for solution for infusion

06/07/2016

First Review Completed

Keytruda
For the treatment of patients with metastatic non-small cell lung carcinoma (NSCLC) whose tumours express PD-L1 (as determined by a validated test) and who have disease progression on or after platinum-containing chemotherapy

PEMBROLIZUMAB
50 mg/vial powder for solution

25/08/2016

Active

Keytruda
For the treatment of patients with previously untreated metastatic non-small cell lung carcinoma whose tumours express PD-L1 (as determined by a validated test) and do not harbor a sensitized EGFR mutation or ALK translocation

PEMBROLIZUMAB
50 mg powder for solution and 100 mg/4 mL solution for infusion

06/03/2018

First Review Completed

Keytruda
For the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of completing neoadjuvant or adjuvant platinum-containing chemotherapy

PEMBROLIZUMAB
50 mg powder for solution for infusion-single use vials

05/03/2018

Active

Keytruda
For the treatment of cutaneous melanoma and Classical Hodgkin Lymphoma (cHL) according to clinical criteria

PEMBROLIZUMAB
50 mg powder for solution

04/08/2020

First Review Completed

Keytruda
For the second treatment of advanced melanoma (re-treatment)

PEMBROLIZUMAB
50 mg solution for infusion 100 mg/4 mL vial

15/08/2019

Active

Keytruda
For the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), in combination with pemetrexed and either cisplatin or carboplatin

PEMBROLIZUMAB
50 mg solution for infusion 100 mg/4 mL vial

23/10/2019

Active

Keytruda
For the adjuvant treatment of melanoma (ADJ MEL)

PEMBROLIZUMAB
50 mg solution for infusion 100 mg/4mL vial

15/03/2019

Active

Keytruda
Treatment of metastatic squamous NSCLC with pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel in adults with no prior systemic chemotherapy treatment for metastatic NSCLC

PEMBROLIZUMAB
50 mg solution for infusion 100 mg/4 mL vial

31/07/2019

Active

Keytruda
For the first line treatment of patients with advanced or metastatic renal cell carcinoma in combination with Inlyta (axitinib) according to clinical criteria

PEMBROLIZUMAB
100 mg/4 mL vial, solution for infusion

16/03/2021

First Review Completed

Keytruda
In first line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)

PEMBROLIZUMAB
25 mg/mL IV solution

15/07/2021

First Review Completed

Keytruda
First line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as monotherapy, in adult patients whose tumours have PD-L1 expression [Combined Positive Score (CPS) ≥ 1] as determined by a validated test.
– First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in combination with platinum and fluorouracil (FU) chemotherapy, in adult patients

PEMBROLIZUMAB
100 mg/4mL solution for infusion vial

30/04/2021

Active

Keytruda
As monotherapy for the first-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer according to clinical criteria

 PEMBROLIZUMAB
100 mg/4 mL solution for infusion vial

15/02/2022

First Review Completed

Keytruda
As monotherapy is indicated for the treatment of adult and pediatric patients with refractory or relapsed classical Hodgkin Lymphoma (cHL) who have failed autologous stem cell transplant (ASCT), or who are not candidates for multi-agent salvage chemotherapy and ASCT

 PEMBROLIZUMAB
100 mg/4 mL solution for infusion vial

12/05/2022

First Review Completed

Keytruda
For the adjuvant treatment of adult patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

 PEMBROLIZUMAB
100 mg/4 mL IV solution

23/08/2022

Active

Keytruda
For the treatment of adult patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continue as monotherapy as adjuvant treatment after surgery

 PEMBROLIZUMAB
100 mg/4 mL IV solution

08/08/2022

Active

Keytruda
As monotherapy is indicated for the treatment of adult and pediatric patients with refractory or relapsed classical Hodgkin Lymphoma (cHL) who have failed autologous stem cell transplant (ASCT), or who are not candidates for multi-agent salvage chemotherapy and ASCT

PEMBROLIZUMAB

100 mg/4 mL solution for infusion vial

12/05/2022

First Review Completed

Keytruda
In combination with chemotherapy for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumors express PD-L1 (Combined Positive Score [CPS] ≥ 10) as determined by a validated test

PEMBROLIZUMAB
100 mg/4 mL solution (IV infusion)

26/09/2022

Active

Keytruda
For treatment, in combination with lenvatinib, of adult patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy, and are not candidates for curative surgery or radiation

PEMBROLIZUMAB
100 mg/4 mL vial solution (IV infusion)

30/11/2022

Active

Keytruda
As monotherapy for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) for endometrial cancer that has progressed following prior therapy and who have no satisfactory alternative treatment options

PEMBROLIZUMAB
100 mg/4 mL vial solution (IV infusion)

06/12/2022

Active

Kisqali
For the treatment of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER 2)-negative, unresectable locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant according to clinical criteria

ribociclib
200 mg tablet

18/11/2020

First Review Completed

Kisqali
For the treatment of patients with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER 2)-negative, unresectable locally advanced or metastatic breast cancer according to clinical criteria

ribociclib
200 mg tablet

18/11/2020

First Review Completed

Kisqali
In combination with letrozole for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as an initial endocrine-based therapy

ribociclib
200 mg tablet

20/09/2019

First Review Completed

Kirsty
Treatment of patients with diabetes mellitus who require insulin for the control of hyperglycemia

INSULIN ASPART
100 units/mL pre-filled pen & 100 units/mL multidose vial

31/01/2023

First Review Completed

Komboglyze
Type 2 diabetes mellitus

saxagliptin HCl / metformin HCl
2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg tablet

12/12/2014

First Review Completed

Kuvan
BH4-responsive Phenylketonuria (PKU)

sapropterin dihydrochloride
100 mg tablet

23/04/2013

Second Review Completed

Kuvan
In conjunction with a Phe-restricted diet to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4)-responsive Phenylketonuria (PKU).

sapropterin dihydrochloride
100 mg and 500 mg powder for oral solution

23/07/2020

Active

Kyleena
For conception control for up to 5 years

levonorgestral
19.5 mg intrauterine system

29/05/2018

Active

Kynmobi
For the acute, intermittent treatment of “OFF” episodes in patients with Parkinson’s disease (PD).

apomorphine hydrochloride
10 mg, 15 mg, 20 mg, 25 mg, and 30 mg soluble film for sublingual administration

06/11/2020

Active

Kyprolis
For use in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 prior lines of therapy

carfilzomib
60 mg lyophilized powder for solution for injection

29/05/2018

Active

Kyprolis
In combination with dexamethasone alone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 lines of therapy

carfilzomib
60 mg lyophilized powder for solution for injection

22/03/2016

Active

Kyprolis
In combination with lenalidomide and dexamethasone or dexamethasone alone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 lines of prior therapy

carfilzomib
10 mg/vial and 30 mg/vial powder for solution (new strengths)

29/05/2018

Active

Lancora
For the treatment of stable chronic heart failure with reduced left ventricular ejection fraction (≤ 35%) in adult patients with NYHA Classes II or III who are in sinus rhythm with a resting heart rate ≥ 77 beats per minute, to reduce the incidence of cardiovascular mortality and hospitalisations for worsening heart failure.

ivabradine HCl
5 mg and 7.5 mg FC tablet

24/10/2018

First Review Completed

Kyprolis
For use in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 prior lines of therapy

carfilzomib
60 mg lyophilized powder for solution for injection

29/05/2018

Active

Kyprolis
In combination with dexamethasone alone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 lines of therapy

carfilzomib
60 mg lyophilized powder for solution for injection

22/03/2016

Active

Kyprolis
In combination with lenalidomide and dexamethasone or dexamethasone alone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 lines of prior therapy

carfilzomib
10 mg/vial and 30 mg/vial powder for solution (new strengths)

29/05/2018

Active

Lancora
For the treatment of stable chronic heart failure with reduced left ventricular ejection fraction (≤ 35%) in adult patients with NYHA Classes II or III who are in sinus rhythm with a resting heart rate ≥ 77 beats per minute, to reduce the incidence of cardiovascular mortality and hospitalisations for worsening heart failure.

ivabradine HCl
5 mg and 7.5 mg FC tablet

24/10/2018

First Review Completed

Lantus (Solostar Prefilled Disposable Pen)
Diabetes, Type 1 & 2

insulin glargine
100 unit/mL solution 3 mL prefilled pen

26/03/2009

First Review Completed

Lapelga
To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

pegfilgrastim
6 mg, sterile solution for injection (10mg/mL)

30/08/2019

First Review Completed

Lartruvo
In combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and for whom treatment with an anthracycline-containing regimen is appropriate

olaratumab
10 mg/mL, solution for infusion

11/07/2018

Active

Latuda
For the acute treatment of patients with schizophrenia

lurasidone hydrochloride
40 mg, 80 mg and 120 mg tablet

27/05/2014

Second Review Completed

Latuda
For the management of the manifestations of schizophrenia after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly

lurasidone hydrochloride
20 mg and 60 mg tablet

22/03/2018

First Review Completed

 

Livtencity
For the treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease who are refractory and/or resistant to one or more prior antiviral therapies.

 

 MARIBAVIR

 200 mg film-coated tablet

07/10/2022

Active

Lemtrada
For the management of adult patients with relapsing remitting multiple sclerosis

alemtuzumab
12 mg/1.2 mL IV solution

26/11/2015

File Closed

Lemtrada
Management of adult patients with relapsing remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies

alemtuzumab
12 mg/1.2 mL IV solution

17/02/2022

First Review Completed

Lenvima
For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RR-DTC)

lenvatinib mesylate
10 mg, 14 mg, 20 mg and 24 mg capsule

31/10/2017

First Review Completed

Lenvima
In combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.

lenvatinib mesylate
10 mg, 14 mg, 20 mg and 24 mg capsule

12/12/2018

Active

Lenvima
For the treatment of unresectable advanced hepatocellular carcinoma according to clinical criteria.

lenvatinib mesylate
4 mg/ dose, 8mg/ dose and 12 mg/ dose capsules

05/03/2020

First Review Completed

Lenvima
In combination with pembrolizumab, for the treatment of adult patients with advanced or metastatic renal cell carcinoma (RCC) with no prior systemic therapy for metastatic RCC.

lenvatinib mesylate
20 mg daily-dose (2x10 mg), 14 mg daily-dose (1x10 mg, 1x4 mg) and 10 mg daily-dose (1x10 mg), 8 mg daily-dose (2x4 mg) capsules

26/05/2022

Active

Levemir FlexTouch
The treatment of type 1 or type 2 diabetes mellitus

insulin detemir
100 unit/mL solution for injection

02/05/2014

First Review Completed

 

Leqvio

Indicated as an adjunct to lifestyle changes, including diet, to further reduce low-density lipoprotein cholesterol (LDL-C) level in adults with the following conditions who are on maximally tolerated dose of a statin, with or without other LDL-C -lowering therapies:
• Heterozygous familial hypercholesterolemia (HeFH), or
• Non-familial hypercholesterolemia with atherosclerotic cardiovascular disease

The effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.

 

INCLISIRAN SODIUM
189 mg/mL (284 mg/1.5 mL) solution for subcutaneous injection

27/10/2022

Active

Libtayo
For the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in patients who are not candidates for curative surgery or curative radiation according to clinical criteria.

cemiplimab
350 mg/7 mL and 250 mg/5 mL (50 mg/mL) concentrate for solution for infusion

03/02/2021

First Review Completed

Libtayo
For the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in ≥ 50% of tumour cells (Tumour Proportion Score [TPS] ≥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.

cemiplimab
350 mg/7 mL (50 mg/mL) concentrate for solution for infusion

02/03/2022

Active

Libtayo
For the treatment of patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor.

cemiplimab
350 mg/7 mL (50 mg/mL) concentrate for solution for infusion

02/22/2022

Active

Lidemol
For topical therapy of corticosteroid responsive acute and chronic skin eruptions

fluocinonide
0.05 % emollient cream

17/01/2012

First Review Completed

Lidex
For topical therapy of corticosteroid responsive acute and chronic skin eruptions

fluocinonide
0.05 % cream

17/01/2012

First Review Completed

Lidex
For topical therapy of corticosteroid responsive acute and chronic skin eruptions

fluocinonide
0.05 % ointment

17/01/2012

First Review Completed

Lidex
For topical therapy of corticosteroid responsive acute and chronic skin eruptions

fluocinonide
0.05 % gel

17/01/2012

First Review Completed

Lixiana
Prevention of stroke and systemic embolic events in patients with atrial fibrillation, in whom anticoagulation is appropriate

edoxaban (as edoxaban tosylate monohydrate)
15 mg, 30 mg and 60 mg FC tablet

29/05/2018

Active

Lixiana
For the treatment of venous thromboembolism (VTE) (deep vein thrombosis [DVT], pulmonary embolism [PE]) and the prevention of recurrent DVT and PE

edoxaban (as edoxaban tosylate monohydrate)
15 mg, 30 mg and 60 mg FC tablet

23/04/2019

First Review Completed

Lodalis
For the reduction of cholesterol blood level in patients with hypercholesterolemia (Frederickson Type IIa) as an adjunct to diet and lifestyle changes

colesevelam hydrochloride
625 mg tablet

27/05/2014

Second Review Completed

Lodalis
For the reduction of cholesterol blood level in patients with hypercholesterolemia (Frederickson Type IIa) as an adjunct to diet and lifestyle changes

colesevelam hydrochloride
3.75 g/pack oral powder for suspension

29/02/2016

First Review Completed

Lokelma
For the treatment of hyperkalemia in adult patients.

sodium zirconium cyclosilicate
5 gram and 10 gram per sachet powder for oral suspension

04/11/2019

Active

LOLO
Combination oral contraceptive

norethindrone acetate/ethinyl estradiol/ethinyl estradiol
1.0 mg/0.010 mg/0.010 mg tablet

27/11/2015

First Review Completed

Lonsurf
Treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents

trifluridine and tipiracil HCl
15 mg/6.14 mg tablets and 20 mg/8.19 mg tablets

18/09/2018

Active

Lonsurf
For the treatment of metastatic gastric cancer (mGC) or adenocarcinoma of the gastroesophageal junction (GEJ) in adult patients according to clinical criteria.

trifluridine and tipiracil HCl
15 mg & 6.14 mg and 20 mg & 8.19 mg tablet

25/03/2021

First Review Completed

Lorbrena
Monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on: crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib.

lorlatinib
25 mg and 100 mg tablet

24/09/2019

Active

Lotemax
Post-operative inflammation following cataract surgery

loteprednol etabonate
0.5% w/v ophthalmic suspension

08/02/2011

Reconsideration Completed

Lucentis
Treatment of visual impairment due to diabetic macular edema (DME)

ranibizumab
10 mg/mL solution for injection

11/12/2012

First Review Completed

Lucentis
For the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

ranibizumab
10 mg/mL solution for injection

23/01/2014

First Review Completed

Lucentis
Neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME), visual impairment due to macular edema secondary to RVO which includes central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO)

ranibizumab
10 mg/mL pre-filled syringe

27/11/2015

First Review Completed

Lucentis
Treatment of visual impairment due to choroidal neovascularisation secondary to pathologic myopia

ranibizumab
10mg/mL IV solution

27/11/2015

First Review Completed

Lumigan RC
Elevated intraocular pressure

bimatoprost
0.01% ophthalmic solution

04/10/2010

First Review Completed

Lumigan RC
Elevated intraocular pressure

bimatoprost
0.01% ophthalmic solution

18/01/2012

First Review Completed

Lutathera
Treatment of unresectable or metastatic, well-differentiated, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults with progressive disease.

lutetium (177 Lu) oxodotreotide
370 MBq/mL sterile solution of intravenous infusion

26/02/2019

Active

Luxiq
For the relief of the inflammatory and pruritic manifestations of moderate to severe psoriasis of the scalp

betamethasonate valerate
0.12% aerosol foam

21/01/2015

Active

Luxturna
For the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

voretigene neparvovec
5 x 1012 vector genomes/mL concentrate for solution for subretinal injection

06/11/2020

Active

Lynparza
For the maintenance treatment of adult patients with platinum sensitive relapsed BRCA mutated epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response to platinum based chemotherapy.

OLAPARIB
100 mg and 150 mg capsules

02/08/2018

First Review Completed

Lynparza
For the maintenance treatment of BRCA-mutated, high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients according to clinical criteria.

OLAPARIB
100 mg and 150 mg tablets

23/12/2020

First Review Completed

Lynparza
As monotherapy for the treatment of adult patients with BRCA or ATM mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with a new hormonal agent.

OLAPARIB
100 mg and 150 mg tablets

15/03/2021

Active

Lynparza
As monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.

OLAPARIB
50 mg capsule

29/08/2018

First Review Completed

Lynparza
For the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of a germline BRCA mutation before Lynparza treatment is initiated

OLAPARIB
100 mg and 150 mg tablet

12/01/2023

Active

Lysodren
For the treatment of inoperable adrenal cortical carcinoma of both functional and non-functional type.

mitotane
500 mg tablet

30/11/2021

First Review Completed

M-Eslon IR
For the management of pain severe enough to require daily, continuous, long-term opioid treatment, and that is opioid-responsive; and for which alternative options are inadequate

morphine sulfate
5 mg, 10 mg, 20 mg and 30 mg extended-release capsules

01/03/2018

Active

MabCampath
Treatment of B-Cell Chronic Lymphocytic Leukemia after failure of fludarabine

alemtuzumab
30 mg/mL vial

29/03/2011

Withdrawn

Mavenclad
As monotherapy for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and delay the progression of disability. Mavenclad is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for MS

cladribine
10 mg tablet

27/02/2018

Active

Maviret
Treatment of Genotype 1-6 Chronic Hepatitis C Infection

glecaprevir/pibrentasvir
100 mg/40 mg tablet

31/07/2020

First Review Completed

Mar-Trientine
For the treatment of Wilson’s Disease according to clinical criteria.

TRIENTINE HYDROCHLORIDE
250 mg capsule

25/03/2022

First Review Completed

Mayzent
For the treatment of secondary progressive multiple sclerosis according to clinical criteria.

siponimod
0.25 mg and 2 mg tablet

25/03/2022

First Review Completed

MDK-Nitisinone
For the treatment of patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

nitisinone
2 mg, 5 mg, 10 mg and 20 mg capsules

23/05/2018

Active

MediSure Blood Glucose Test Strip
To measure the concentration of glucose in the blood

glucose oxidase

27/11/2015

First Review Completed

Medisure Empower Blood Glucose Test Strips
To measure the concentration of glucose in the blood

FAD-GLUCOSE DEHYDROGENASE (FAD-GDH)

23/11/2022

Active

Mekinist
For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation

trametinib
0.5 mg and 2 mg tablet

21/08/2014

First Review Completed

Metadol-D
For methadone maintenance treatment for addiction

methadone HCl
10 mg/mL liquid (oral concentrate)

10/12/2014

First Review Completed

Metadol-D
For methadone maintenance treatment for addiction

methadone HCl
1 mg/mL oral solution

24/06/2015

Active

Methadose
For substitution treatment in opioid drug dependence in adults

methadone HCl
10 mg/mL

23/06/2014

First Review Completed

Metoject Subcutaneous
Psoriasis/psoriatic arthritis, rheumatoid arthritis

methotrexate (supplied as methotrexate sodium)
10 mg/0.2 mL, 12.5 mg/0.25 ml solution (subcutaneous) single-use pre-filled syringe

28/02/2020

First Review Completed

Metoject Subcutaneous
Psoriasis/psoriatic arthritis, rheumatoid arthritis

methotrexate (supplied as methotrexate sodium)
7.5 mg/0.15 mL, 17.5 mg/0.35 mL, 20 mg/0.4 mL, 22.5 mg/0.45 mL and 25 mg/0.5 mL solution (subcutaneous) single-use pre-filled syringe

05/04/2018

First Review Completed

Metoject Subcutaneous
Psoriasis/psoriatic arthritis, rheumatoid arthritis

methotrexate (supplied as methotrexate sodium)
15 mg/0.3 mL solution (subcutaneous) single-use pre-filled syringe

30/04/2019

First Review Completed

Metvix
Superficial basal cell carcinoma

methyl aminolevulinate
168 mg/gm topical cream

06/07/2011

First Review Completed

Mezera
For the treatment of mildly active ulcerative colitis of the sigmoid colon and rectum.

MESALAZINE
1 g/ACT rectal foam

16/11/2018

Active

Mezera
For the treatment of acute mild to moderate ulcerative proctitis.

MESALAZINE
1 g rectal suppository

28/05/2019

Active

Mezera
For the induction of remission in adult patients with active mild to moderate ulcerative colitis

MESALAZINE
500 mg delayed-release tablets

23/11/2022

Active

Mictoryl/ Mictoryl Pediatric
For symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in patients with overactive bladder

propiverine hydrochloride
30 mg and 45 mg modified-release capsule, 5 mg tablet

29/05/2017

Active

Mifegymiso
For medical termination of a developing intra-uterine pregnancy with a gestational age up to 49 days as measured from the first day of the Last Menstrual Period in a presumed 28-day cycle

mifepristone/misoprostol
200 mg/200 mcg Fixed Combination tablet-tablet packs

30/05/2017

First Review Completed

Monoferric
For the treatment of patients with Iron Deficiency Anemia (IDA) who meet ALL the following criteria:
– Patient has documented diagnosis of IDA confirmed by laboratory testing results (e.g. hemoglobin, ferritin); AND
– Patient’s IDA has experienced a failure to respond, documented intolerance, or contraindication to an adequate trial (i.e. at least 4 weeks) of at least one oral iron therapy; AND
– Patient’s IDA has experienced a failure to respond, documented intolerance, or contraindication to an adequate trial (i.e. at least 4 weeks) of at least one oral iron therapy; AND
– Monoferric is administered in a setting where appropriate monitoring and management of hypersensitivity reactions can be provided to the patient.

iron isomaltoside 1000 for injection
100 mg elemental iron/mL, solution intravenous

26/02/2021

First Review Completed

Monoprost
For the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension

latanoprost
50 mcg/mL solution ophthalmic

03/08/2018

Active

Monurol Sachet
For the treatment of uncomplicated urinary tract infections

fosfomycin tromethamine
3 g sachet oral powder

04/08/2015

Reconsideration Completed

Movapo
For the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) in patients with advanced Parkinson’s disease.

apomorphine HCl
30 mg/3 mL pre-filled pen and 20 mg/2 mL ampoule

20/09/2019

First Review Completed

Mozobil
In combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma

plerixafor
24 mg/1.2 mL (20 mg/mL) subcutaneous solution

20/02/2014

First Review Completed

Multaq
Atrial fibrillation

dronedarone hydrochloride
400 mg FC tablet

16/08/2011

Second Review Completed

Mvasi
For the treatment of Platinum-Resistant Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PROC) according to clinical criteria.

bevacizumab
25 mg/mL (100 mg/4mL) and 25 mg/mL (400 mg/16mL) IV solution for injection

15/04/2020

First Review Completed

Mvasi
In combination with paclitaxel, topotecan or pegylated liposomal doxorubicin, is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens. These patients should not have received prior VEGF-targeted therapy including MVASI.

bevacizumab
25 mg/mL IV solution for injection

16/03/2020

Active

MyGlucoHealth Test Strips
To measure the concentration of glucose in the blood

glucose oxidase

28/11/2013

First Review Completed

Mylotarg
For the treatment of acute myeloid leukemia according to clinical criteria.

gemtuzumab ozogamicin
4.5 mg lyophilized cake or powder for solution

15/11/2021

First Review Completed

Nypozi
Hematopoietic Agent
Granulocyte Colony Stimulating Factor

filgrastim
600 µg/mL SC, IV, solution (300 µg/0.5 mL prefilled syringe) and 600 µg/mL SC, IV, solution (480 µg/0.8 mL prefilled syringe)

30/06/2022

Active

Myrbetriq
For the treatment of overactive bladder

mirabegron
25 mg and 50 mg ER tablet

24/06/2015

First Review Completed

Nerlynx
For the early stage hormone receptor positive HER 2-overexpressed amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.

neratinib
40 mg tablet

12/02/2020

Active

Nesina
To improve glycemic control in adult patients with type 2 diabetic mellitus

alogliptin benzoate
6.25 mg, 12.5 mg and 25 mg tablet

04/08/2015

First Review Completed

Neupogen
Primary prophylaxis of febrile neutropenia

filgrastim
300 mcg/mL vial and 480 mcg/1.6 mL injection

04/10/2010

First Review Completed

Neupogen
Primary prophylaxis of febrile neutropenia

filgrastim
300 mcg/mL vial and 480 mcg/1.6 mL injection

24/08/2011

First Review Completed

Neupogen
For primary prophylaxis of febrile neutrophilia in patients undergoing adjuvant breast cancer treatment with the TC regimen

filgrastim
300 mcg/mL vial and 480 mcg/1.6 mL injection

31/07/2013

First Review Completed

Neupogen
Granulocyte colony stimulating factor

filgrastim
300 mcg (0.5 mL of 600 mcg/mL solution) & 480mcg (0.8 mL of 600 mcg/mL solution) pre-filled syringe

23/08/2017

First Review Completed

Neupro
The treatment of the signs and symptoms of idiopathic Parkinson’s disease

rotigotine
2 mg/24hr, 4 mg/24hr, 6 mg/24hr and 8 mg/24hr transdermal patch

24/06/2015

First Review Completed

Neupro
As adjunctive therapy to levodopa for the treatment of patients with advanced stage Parkinson’s disease

rotigotine
2 mg/24h, 4 mg/24h, 6 mg/24h, 8 mg/24h transdermal system patch

31/10/2017

First Review Completed

Nexavar
Metastatic renal cell carcinoma

sorafenib tosylate
200 mg tablet

04/10/2010

First Review Completed

Nexavar
Treatment of patients with locally advanced or metastatic, progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine

sorafenib
200 mg tablet

10/12/2015

First Review Completed

Nexplanon
Prevention of pregnancy for up to 3 years.

ETONOGESTREL
68 mg/implant, SC implant

17/12/2021

First Review Completed

Nimotop
Subarachnoid hemorrhage (SAH)

nimodipine
30 mg tablet

19/10/2011

First Review Completed

Ninlaro
For the treatment of adult patients with multiple myeloma who have received at least one prior therapy and have high risk cytogenetics or have received at least two prior therapies

ixazomib citrate
2.3 mg, 3 mg and 4 mg capsule

26/09/2017

Active

Ninlaro
In combination with lenalidomide and dexamethasone (Ld) is indicated for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.

ixazomib citrate
2.3 mg, 3 mg, and 4 mg capsules

23/04/2019

Active

NITISINONE TABLETS
For the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

nitisinone
2 mg, 5 mg, and 10 mg tablets

24/09/2018

Active

Nitoman
Hyperkinetic movement disorders

tetrabenazine
25 mg tablet

04/10/2010

First Review Completed

Nivestym
Cancer Patients Receiving Myelosuppressive Chemotherapy; Patients with Acute Myeloid Leukemia; Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation; Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy; Patients with Severe Chronic Neutropenia (SCN); Patients with HIV Infection.

filgrastim
300 mcg/0.5 mL prefilled syringe, 480 mcg/0.8 mL prefilled syringe, 300 mcg/mL single-dose vial, 480 mcg/1.6mL single-dose vial.

31/07/2020

First Review Completed

Norditropin NordiFlex
For endogenous growth hormone deficiency

 

SOMATROPIN
5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL subcutaneous solution

04/08/2015

First Review Completed

Norditropin SimpleXx
Growth disturbance in children born small for gestational age

 

SOMATROPIN
5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL solution

04/08/2015

First Review Completed

Norditropin SimpleXx
Growth failure in children due to growth hormone deficiency

 

SOMATROPIN
5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL solution

04/08/2015

First Review Completed

 

 Norditropin FlexPro

 For endogenous growth hormone deficiency

 

SOMATROPIN

5 mg/1.5 mL, 10 mg/1.5 mL & 15 mg/1.5 mL solution (SC injection)

16/09/2022

Active

Noromby
The prophylaxis of thromboembolic disorders (deep vein thrombosis) in patients undergoing: - orthopedic surgery of the hip or knee. In addition, NOROMBY is indicated in hospital or after hospital discharge for long-term prevention of venous thromboembolic diseases following hip replacement surgery. - high risk abdominal, gynecological, or urological surgeries; - colorectal surgery.
– The prophylaxis of deep vein thrombosis (DVT) in medical patients who are at moderate risk of DVT and who are bedridden due to moderate to severe acute cardiac insufficiency (NYHA Class III or IV heart failure), acute respiratory failure revealing or complicating chronic respiratory insufficiency not requiring ventilatory support and acute respiratory infections (excluding septic shock), who require short-term prophylaxis of deep vein thrombosis.
– The prevention of thrombus formation in the extra-corporeal circulation during hemodialysis.
– The treatment of deep vein thrombosis, with or without pulmonary embolism.
– The treatment of unstable angina or non-Q-wave myocardial infarction, concurrently with ASA.
– Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

enoxaparin sodium
20 mg/0.2 mL prefilled syringe

30/06/2021

First Review Completed

Noromby AND Noromby HP
The prophylaxis of thromboembolic disorders (deep vein thrombosis) in patients undergoing: - orthopedic surgery of the hip or knee. In addition, NOROMBY is indicated in hospital or after hospital discharge for long-term prevention of venous thromboembolic diseases following hip replacement surgery. - high risk abdominal, gynecological, or urological surgeries; - colorectal surgery.
– The prophylaxis of deep vein thrombosis (DVT) in medical patients who are at moderate risk of DVT and who are bedridden due to moderate to severe acute cardiac insufficiency (NYHA Class III or IV heart failure), acute respiratory failure revealing or complicating chronic respiratory insufficiency not requiring ventilatory support and acute respiratory infections (excluding septic shock), who require short-term prophylaxis of deep vein thrombosis.
– The prevention of thrombus formation in the extra-corporeal circulation during hemodialysis.
– The treatment of deep vein thrombosis, with or without pulmonary embolism.
– The treatment of unstable angina or non-Q-wave myocardial infarction, concurrently with ASA.
– Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

enoxaparin sodium
30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL AND 120 mg/0.8 mL, 150 mg/mL pre-filled syringes

30/06/2021

First Review Completed

Norvir
For the treatment of HIV infection

ritonavir
100 mg FC tablet

21/02/2012

First Review Completed

NovoRapid FlexTouch
Treatment of patients with diabetes mellitus requiring insulin for the control of hyperglycemia

insulin aspart
100 U/mL prefilled disposable pen

23/04/2013

First Review Completed

Nplate
Chronic immune thrombocytopenia purpura

romiplostim
250 mcg/0.5 mL and 500 mcg/mL powder for injection

16/06/2011

Second Review Completed

Nubeqa
For the treatment of high risk non-metastatic castration resistant prostate cancer (nmCRPC) according to clinical criteria

DAROLUTAMIDE
300 mg tablet

08/06/2021

First Review Completed

Nubeqa
For the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel

DAROLUTAMIDE
300 mg tablet

06/12/2022

Active

Nucala
For add on maintenance treatment of adult patients with severe eosinophilic asthma who are inadequately controlled with high-dose inhaled corticosteroids and an additional asthma controller(s (e.g. LABA) and have high blood eosinophil count of ≥ to 150 cells/uL at initiation of treatment with Nucala or ≥ to 300 cells/uL in the past 12 months

mepolizumab
100 mg / mL powder for solution (subcutaneous)

15/06/2018

First Review Completed

Nucala
As add-on maintenance treatment of adult patients with severe eosinophilic asthma who:
– are inadequately controlled with high-dose inhaled corticosteroids and an additional asthma controller(s) (e.g. LABA), and
– have a blood eosinophil count of ≥ 150 cells/µL (0.15 GI/L) at initiation of treatment with NUCALA OR ≥ 300 cells/µL (0.3 GI/L) in the past 12 months.

mepolizumab
100 mg / mL powder for solution (subcutaneous)

13/02/2020

Active

Nucala
For add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by intranasal corticosteroids alone.

mepolizumab
100 mg/mL, reconstituted (144 mg/vial) lyophilized powder for solution (SC), 100 mg/mL (100 mg/ autoinjector) autoinjector (SC) & 100 mg/mL (100 mg/ syringe) pre-filled syringe (SC)

19/08/2022

Active

Nucynta
For use in patients with pain severe enough to require daily, continuous, long-term opioid treatment, and that is opioid responsive and for which alternative treatment options are adequate

tapentadol
50 mg, 100 mg, 150 mg, 200 mg, and 250 mg extended-release tablets

30/01/2019

Active

Nucynta CR
For the management of moderate to moderately severe pain in adults

tapentadol
50 mg, 100 mg, 150 mg, 200 mg and 250 mg CR tablet

29/03/2012

First Review Completed

Nutropin AQ Nuspin
The treatment of children who have growth failure. Treatment of short stature associated with Turner syndrome

somatropin
5 mg/2 mL/20 mg/2 mL subcutaneous solution for injection

27/11/2015

First Review Completed

Nutropin AQ NuSpin 10
Treatment of growth hormone deficiency in adults and growth failure in children

somatropin
10 mg/2 mL disposable injection pen

27/05/2014

First Review Completed

NYDA
Treatment of scalp hair in case of infestation with head lice

dimeticone
50 %w/w topical solution

28/11/2013

First Review Completed

Nyvepria
To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

PEGFILGRASTIM
10 mg/mL SC solution

31/08/2021

First Review Completed

Ocaliva
For the treatment of primary biliary cholangitis1 (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA

obeticholic acid
5 mg & 10 mg oral tablets

24/10/2018

First Review Completed

Ocrevus
As a monotherapy for the treatment of relapsing-remitting multiple sclerosis

ocrelizumab
30 mg/mL concentrate for infusion

11/07/2018

Active

Ocrevus
As monotherapy for the treatment of adult patients with primary progressive multiple sclerosis (PPMS) to delay disease progression and reduce deterioration in walking speed.

ocrelizumab
30 mg/mL concentrate for infusion (300 mg/10 mL vial)

31/10/2019

First Review Completed

Odefsey
As a complete regimen for the treatment of treatment-naïve and virologically suppressed adults infected with HIV-1 with no known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or FTC, and with a viral load ≤ 100,000 copies/mL.

emtricitabine/rilpivirine/tenofovir alafenamide
200 mg/25 mg/ 25 mg tablet

29/08/2018

First Review Completed

Odefsey
As a complete regimen for the treatment of treatment-naïve and virologically suppressed adults infected with HIV-1 with no known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or FTC, and with a viral load ≤ 100,000 copies/mL.

emtricitabine/rilpivirine/tenofovir alafenamide
200 mg/25 mg/ 25 mg tablet

29/08/2018

First Review Completed

Odomzo
For the treatment of adult patients with histologically confirmed locally advanced basal cell carcinoma (laBCC) that is not amenable to radiation therapy or curative surgery.

sonidegib
200 mg capsule

17/08/2020

Active

Ofev
Treatment of Idiopathic Pulmonary Fibrosis (IPF)

nintedanib esilate
100 mg and 150 mg capsule

15/09/2016

First Review Completed

Ofev
For the treatment of chronic fibrosing interstitial lung disease according to clinical criteria.

nintedanib esilate
100 mg and 150 mg capsules

29/04/2022

First Review Completed

Ogivri
For the treatment of breast and gastric cancers, according to clinical criteria.

 TRASTUZUMAB
150 mg and 440 mg lyophilized powder for intravenous infusion

15/11/2019

First Review Completed

Ogivri
OGIVRI can be used in combination with pertuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease

TRASTUZUMAB
150 mg/vial & 440 mg/vial IV, powder for solution

15/09/2022

First Review Completed

Oxlumo
For the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients

LUMASIRAN
94.5 mg/0.5 mL SC solution

27/09/2022

Active

Ngenla
For the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency).

SOMATROGON
24 mg/1.2 mL (20 mg/mL) and 60 mg/1.2 mL (50 mg/mL) SC injection, single-use prefilled pen

25/03/2022

Active

Olmetec
Mild to moderate essential hypertension

olmesartan medoxomil
20 mg and 40 mg tablet

29/04/2010

First Review Completed

Olmetec Plus
Hypertension

olmesartan medoxomil/hydrochlorothiazide
20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg tablet

29/04/2010

First Review Completed

Olumiant
In combination with methotrexate (MTX) is indicated for reducing signs and symptoms of moderate to severe rheumatoid arthritis (RA).

baricitinib
2 mg tablet

31/08/2021

First Review Completed

Palynziq
To reduce blood phenylalanine concentrations in patients with phenylketonuria aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/L) despite dietary management

PEGVALIASE
2.5 mg / 0.5 mL, 10 mg / 0.5 mL and 20 mg / mL SC Solution

08/07/2022

Active

Padcev
For the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed deathligand 1 (PD-L1) inhibitor therapy.

ENFORTUMAB VEDOTIN
20 mg IV, powder for solution

02/12/2021

Active

Omnaris
Allergic Rhinitis (seasonal and perennial)

ciclesonide
50 mcg nasal spray

25/09/2009

First Review Completed

Omnitrope
Growth hormone deficiency in children and adults

somatropin
5.8 mg/vial solution

17/11/2010

First Review Completed

Omnitrope
Growth hormone deficiency in children and adults

somatropin
15 mg/1.5 mL solution for injection

02/03/2018

Active

Onbrez Breezhaler
For treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)

indacaterol maleate
75 mcg inhalation powder hard capsules

23/04/2013

First Review Completed

OneTouch Verio Glucose Test Strips
To measure the concentration of glucose in the blood

GDH-FAD Glucose Dehydrogenase

25/11/2013

First Review Completed

Onglyza
Diabetes, Type 2

saxagliptin
5 mg tablet

21/02/2012

Reconsideration Completed

Onglyza
Diabetes, Type 2

saxagliptin
2.5 mg tablet

02/01/2013

First Review Completed

Onivyde
Treatment of patients metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have disease progression following gemcitabine-based therapy

irinotecan hydrochloride trihydrate
4.3 mg/mL suspension for injection

28/05/2018

Active

Onpattro
For the treatment of polyneuropathy in patients with hereditary transthyretin mediated amyloidosis (hATTR) according to clinical criteria.

patisiran
2 mg/1 mL solution for infusion

08/04/2021

First Review Completed

Onsolis
For the management of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving, and who are intolerant to, opioid therapy for their persistent baseline cancer pain

fentanyl citrate
200 mcg, 400 mcg, 600 mcg, 800 mcg and 1200 mcg buccal soluble film

30/05/2012

First Review Completed

Onstryv
Indicated as an add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson’s disease (PD) in patients experiencing “off” episodes while on a stable dose of levodopa.

safinamide mesylate
50 mg and 100 mg tablet

26/08/2019

Active

Ontruzant

Early Breast Cancer (EBC)

Metastatic Breast Cancer (MBC)

Metastatic Gastric Cancer (MGC)

TRASTUZUMAB
150 mg/vial and 440 mg/vial IV, Powder for Solution

15/09/2022

First Review Completed

Opdivo
For the first-line treatment of adult patients with advanced (unresectable or metastatic) melanoma

nivolumab
40 mg/4 mL and 100 mg/10 mL solution

31/03/2017

First Review Completed

Opdivo
For advanced or metastatic renal cell carcinoma who have received prior anti-angiogenic treatment

nivolumab
40 mg/4 mL and 100 mg/10 mL solution

31/03/2017

First Review Completed

Opdivo
For the treatment of patients with advanced non-small cell lung cancer (NSCLC) who progressed on or after chemotherapy

nivolumab
40 mg/4 mL and 100mg/10mL solution

31/03/2017

First Review Completed

Opdivo
For the treatment of patients with classical Hodgkin Lymphoma (cHL) that has relapsed or progressed after autologous stem cell transplantation (ASCT) and brentuximab vedotin according to clinical criteria.

nivolumab
40 mg/4 mL and 100 mg/10 mL solution

01/29/2020

First Review Completed

Opdivo
For the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy.

nivolumab
40 mg/4 mL, 100 mg/10 mL single-use vials and 5 mg/mL vials

06/04/2018

First Review Completed

Opdivo
OPDIVO, in combination with ipilimumab for previously untreated intermediate and poor-risk patients with advanced metastatic renal carcinoma (RCC).

nivolumab
10 mg/mL Intravenous Infusion

15/05/2019

First Review Completed

Opdivo
For the treatment of adult patients with advanced (not amenable to curative therapy or local therapeutic measures) or metastatic HCC that are intolerant to or have progressed on sorafenib therapy.

nivolumab
40 mg/4mL & 100 mg/10mL IV solution

16/11/2018

Active

Opdivo
Adjuvant treatment for completely resected Stage 3 and 4 melanoma.

nivolumab
40 mg/4 mL and 100 mg/10 mL solution

01/04/2019

Active

Yervoy and Opdivo
OPDIVO (nivolumab) in combination with YERVOY (ipilimumab) and 2 cycles of chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no known EGFR or ALK genomic tumor aberrations.

ipilimumab and nivolumab
5 mg/mL IV solution, 40 mg/ 4mL solution and 100 mg/10mL solution

12/05/2022

First Review Completed

Opdivo and Yervoy
OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.

nivolumab and ipilimumab
40 mg/4 mL (10 mg/mL), 100 mg/10 mL (10 mg/mL) AND 5 mg/mL (50 mg/10 mL), 5 mg/mL (200 mg/40 mL) IV solution

12/05/2022

First Review Completed

Opdivo & Yervoy
Opdivo in combination with Yervoy for the treatment of unresectable or metastatic melanoma in previously untreated adults, regardless of BRAF status

nivolumab & ipilimumab
40 mg/4 mL, 100 mg/10 mL single-use vials and 5 mg/mL vials

23/04/2019

First Review Completed

Opsumit
For the treatment of patients with pulmonary arterial hypertension according to clinical criteria

macitentan
10 mg tablet

20/04/2021

First Review Completed

Oralair
For the treatment of symptoms of moderate to severe seasonal grass pollen allergic rhinitis

grass pollen allergen extract
100 IR and 300 IR sublingual tablet

25/03/2014

First Review Completed

Orencia
Juvenile idiopathic arthritis and juvenile rheumatoid arthritis

abatacept
250 mg/15 mLvial powder for injection

11/05/2011

First Review Completed

Orencia
For adult patients with severe active rheumatoid arthritis who may and who have severe active rheumatoid arthritis despite the optimal use of various disease modifying anti-rheumatic drugs (DMARDs)

abatacept
125 mg / mL pre-filled syringes for subcutaneous injection

16/01/2014

First Review Completed

Orfadin
For the treatment of patients with hereditary tyrosinemia type I (HT-1) in combination with dietary restriction of tyrosine and phenylalanine

nitisinone
2 mg, 5 mg, 10 mg and 20 mg capsules

29/11/2018

Active

Orfadin
Treatment of adult and pediatric patients with confirmed diagnosis of hereditary tyrosinemia type I (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

nitisinone
4 mg/mL oral suspension

07/09/2018

Active

Orkambi
For the treatment of a subpopulation of patients with cystic fibrosis (CF): those aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene

lumacaftor & ivacaftor
200 mg & 125 mg tablet

25/06/2021

First Review Completed

Orkambi
For the treatment of cystic fibrosis (CF) in patients 6 years of age and older who are homozygous for F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

lumacaftor & ivacaftor
100 mg and 125 mg tablet

25/06/2021

First Review Completed

Osnuvo
– For the treatment of postmenopausal women with severe osteoporosis who are at high risk of fracture or who have failed or are intolerant to previous osteoporosis therapy.
– To increase bone mass in men with primary or hypogonadal severe osteoporosis who have failed or are intolerant to previous osteoporosis therapy. The effects of teriparatide on risk for fracture in men have not been demonstrated.
– For the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men and women who are at increased risk for fracture.

teriparatide
250 mcg/mL, sterile solution for subcutaneous injection

29/09/2022

First Review Completed

Otezla
For the treatment of adult patients with moderate to severe psoriasis who are candidates for phototherapy or systemic therapy

apremilast
10 mg, 20 mg and 30 mg tablet

09/02/2016

First Review Completed

Otezla
For use alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response, intolerance, or contraindication to a prior disease-modifying anti-rheumatic drug (DMARD)

apremilast
10 mg, 20 mg, 30 mg (tablet (starter pack kit) and 30 mg tablet

31/03/2016

Active

OxyContin
Opioid Analgesic

oxycodone hydrochloride
15 mg, 30 mg and 60 mg tablet

05/05/2010

First Review Completed

OxyNEO
For the relief of moderate to severe pain requiring the continues use of an opioid analgesic preparation

oxycodone hydrochloride
10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg tablet

21/02/2012

First Review Completed

Ozanex
For the treatment of impetigo in patients 2 months of age and older.

ozenoxacin
1% w/w topical antibiotic cream

10/01/2019

Active

Ozempic
reducing the signs and symptoms of moderate to severe seasonal short ragweed pollen induced allergic rhinitis

semaglutide
1.34 mg/mL subcutaneous solution
(multidose prefilled pen dispenses
1mg dose), and 1.34 mg/mL
subcutaneous solution
(multidose prefilled pen dispenses
0.25mg or 0.5mg dose).

20/09/2019

First Review Completed

Ozurdex
For the treatment of macular edema following central retinal vein occlusion (CRVO)

DEXAMETHASONE
0.7 mg intravitreal implant

16/08/2012

First Review Completed

Ozurdex
For the treatment of adult patients with diabetic macular edema who are pseudophakic and have had an inadequate response to prior anti-VEGF therapy

DEXAMETHASONE
0.7 mg intravitreal implant

28/09/2022

Active

Opsynvi
For the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to reduce morbidity in patients of WHO functional class (FC) II or III whose PAH is idiopathic, heritable or associated with connective tissue disease or congenital heart disease.
OPSYNVI should be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.

macitentan and tadalafil
10 mg and 40 mg film-coated tablets

08/03/2022

Active

Osphena
Osphena is indicated in postmenopausal women for the treatment of moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM).

OSPEMIFENE
60 mg tablet

22/02/2022

Active

Ozurdex
For the treatment of adult patients with diabetic macular edema (DME) who are pseudophakic and who are: - Unsuitable for anti-VEGF therapy; OR - Have inadequate response to prior anti-VEGF therapy

dexamethasone
0.7 mg intravitreal implant

15/06/2018

Active

Oxervate
The treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.

CENEGERMIN
20 mcg/mL ophthalmic solution

02/03/2022

Active

Onureg
For maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation (HSCT)

AZACITIDINE
200 mg & 300 mg tablet

14/11/2022

First Review Completed

Pdp- Levetiracetam
For use as adjunctive therapy in the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy, and who have swallowing difficulty or cannot take a solid oral pill

LEVETIRACETAM
100 mg/mL oral solution

21/12/2022

First Review Completed

Pegasys/Pegasys RBV
Treatment of adult patients with chronic Hepatitis C

peginterferon alfa-2a /peginterferon alfa-2a & ribavirin
180 mcg/0.5 mL solution;
180 mcg/0.5 mL/250 mg solution/tablet kit;
180 mcg/0.5 mL/200 mg solution/tablet kit

10/12/2015

First Review Completed

Pentasa
Treatment of mild to moderate active ulcerative colitis and for long-term maintenance therapy in order to maintain remission and prevent relapse of active disease and Management of mild to moderate Crohn’s Disease and maintenance of Crohn’s Disease in remission induced by surgery or medication

mesalazine (5-aminosalicylic acid)
1g ER tablet

27/11/2015

First Review Completed

PeriOlimel 2.5% E, Olimel 5.7% E, Olimel 5.7%, Olimel 7.6% E
For parenteral nutrition (PN) for adults when oral or enteral (EN) nutrition is impossible, insufficient or contraindicated.

amino acids with or without electrolytes, dextrose, lipids
2.5% w/v & 0.4% w/v,
7.5% w/v, 3% w/v
5.7% w/v & 0.7% w/v,
11% w/v,
4% w/v 5.7% w/v,
11% w/v, 4% w/v
7.6% w/v & 0.8% w/v,
7.3% w/v, 3.5% w/v,
IV emulsion

07/04/2021

Active

Perjeta
In combination with HERCEPTIN and chemotherapy for 18 cycles for the treatment of HER2-positive early breast cancer patients at high risk of recurrence.

pertuzumab
420 mg/14 mL vial, liquid for infusion

16/11/2018

Active

Perjeta-Herceptin Combo Pack
In combination with trastuzumab and docetaxel for the treatment of patients with HER2- positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease

pertuzumab
420 mg/14 mL vial concentrate for solution for infusion

28/11/2013

First Review Completed

Perjeta-Herceptin Combo Pack
In combination with HERCEPTIN® (trastuzumab) and chemotherapy prior to surgery for the treatment of patients with HER2+ locally advanced, inflammatory, or early stage breast cancer.

pertuzumab / trastuzumab
420 mg/14 mL / 440 mg/vial

10/12/2015

First Review Completed

Piqray
In combination with fulvestrant, is indicated for the treatment of
postmenopausal women, and men, with hormone receptor-positive, HER2-negative,
PIK3CA- mutated advanced or metastatic breast cancer after disease progression
following an endocrine-based regimen.

ALPELISIB
150 mg, 200 mg, 50 mg + 200 mg tablets

01/12/2021

Active

Pheburane
As adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase

sodium phenylbutyrate
483 mg/granules

28/05/2018

Active

Phesgo
Phesgo with a taxane for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. PHESGO should be administered until disease progression or unmanageable toxicity.

pertuzumab / trastuzumab
80 mg/mL / 40 mg/mL and
60 mg/mL / 60 mg/mL SC solution

16/06/2021

Active

Picato
Topical treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (AK) in adults

ingenol mebutate
0.015% and 0.05% topical gel

10/12/2015

First Review Completed

Pifeltro
In combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to doravirine.

doravirine
100 mg FC tablet

31/10/2019

First Review Completed

Plan B
As an emergency contraceptive that can prevent pregnancy

levonorgestrel
1.5 mg tablet

15/06/2018

First Review Completed

Plegridy
Treatment of relapsing remitting multiple sclerosis (RRMS) for adult patients: To reduce the frequency of clinical exacerbations and to slow the progression of disability

peginterferon beta-1a
63 mcg, 94 mcg & 125 mcg
pre-filled syringe or pen

31/03/2017

First Review Completed

Pms-Fluoxetine
Antidepressant / Antiobsessional / Antibulimic

fluoxetine hydrochloride
40 mg and 60 mg capsules

26/10/2020

Active

Polivy
POLIVY, in combination with bendamustine and rituximab, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who are not eligible for autologous stem cell transplant and have received at least one prior therapy

polatuzumab vedotin
20 mg per mL powder for concentrate for solution for infusion

06/05/2022

First Review Completed

Polivy
POLIVY, in combination with bendamustine and rituximab, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who are not eligible for autologous stem cell transplant and have received at least one prior therapy

polatuzumab vedotin
140 mg/vial, powder for concentrate for solution for infusion

06/01/2021

First Review Completed

Poteligeo
For the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

MOGAMULIZUMAB
4 mg/mL IV, solution

20/06/2022

Active

Pemazyre
For the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor 2 (FGFR2) fusion or other rearrangement.

PEMIGATINIB
4.5 mg, 9 mg, and 13.5 mg tablets

24/01/2022

Active

Pomalyst
Multiple myeloma (MM) for whom both bortezomib and lenalidomide have failed and who have received at least two prior treatment regimens and have demonstrated disease progression on the last regimen.

pomalidomide
1 mg, 2 mg, 3 mg and 4 mg capsule

25/02/2015

First Review Completed

Pomalyst
In combination with bortezomib and dexamethasone (PVd) for patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

pomalidomide
1 mg, 2 mg, 3 mg and 4 mg capsule

24/09/2019

Active

Ponstan
For the relief of acute pain of moderate severity in various conditions

mefenamic acid
250 mg capsule

15/06/2018

File Closed

Posanol
Treatment of invasive aspergillosis

posaconazole
40 mg/mL oral suspension

23/04/2013

Reconsideration Completed

Posanol
Prophylaxis of Aspergillus and Candida infections and treatment of invasive aspergillosis

posaconazole
100 mg DR tablet

05/05/2015

First Review Completed

Pradaxa
Venous thromboembolism prevention

dabigatran etexilate mesilate
75 mg and 110 mg capsule

02/05/2013

Second Review Completed

Pradaxa
Prevention of stroke and systemic embolism in patients with atrial fibrillation

dabigatran etexilate mesilate
110 mg and 150 mg capsule

23/04/2013

First Review Completed

Praluent
As an adjunct to diet and MTS therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of LDL-C

alirocumab
75 mg/mL and 150 mg/mL
solution for injection

21/03/2019

First Review Completed

Prevymis
For the prophylaxis of cytomegalovirus (CMV) infection in adult patients who have received an allogeneic hematopoietic stem cell transplant (HSCT) according to clinical criteria.

letermovir
240 mg and 480 mg tablets,
and Solution for injection,
20 mg/mL, 240 mg/vial
and 480 mg/vial, intravenous

22/01/2020

First Review Completed

Prezcobix
In combination with other antiretroviral agents for the treatment of HIV infection in treatment-naïve and in treatment-experienced patients without DRV RAMS.

darunavir/ cobicistat
800 mg/150 mg tablet

06/07/2016

First Review Completed

Prezista
HIV in pediatric patients

darunavir ethanolate
75 mg tablet

27/11/2015

First Review Completed

Prezista
HIV in pediatric patients

darunavir ethanolate
150 mg tablet

27/11/2015

First Review Completed

Prezista
HIV in previously untreated adult patients

darunavir ethanolate
400 mg tablet

27/11/2015

First Review Completed

Prezista
HIV infection in previously untreated adult patients

darunavir ethanolate
600 mg tablet

27/11/2015

First Review Completed

Prezista
Treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult patients, when taken in combination with low-dose ritonavir and other antiretrovirals

darunavir ethanolate
800 mg tablet

27/11/2015

First Review Completed

Pristiq
Major depressive disorder

desvenlafaxine succinate
50 mg and 100 mg ER tablet

04/10/2010

Reconsideration Completed

Probuphine
For the management of opioid use disorder in combination with counseling and psychosocial support in adult patients according to specific criteria

buprenorphine hydrochloride
80 mg subdermal implant

30/04/2020

First Review Completed

Procysbi
For the treatment of nephropathic cystinosis

cysteamine bitartrate
25 mg and 75 mg DR capsules

13/09/2018

First Review Completed

Prolastin
Congenital alpha1-antitrypsin deficiency

alpha1-proteinase inhibitor (human)
1000 mg/vial powder for solution

17/08/2011

Second Review Completed

Propylthiouracil Tablets

Thyroid therapy

 

PROPYLTHIOURACIL
50 mg tablet

30/09/2022

Active

Prolia
Postmenopausal women with osteoporosis at high risk for fracture

denosumab
60 mg/mL pre-filled syringe

21/02/2012

First Review Completed

Prolia
As a treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy

denosumab
60 mg/mL subcutaneous solution

05/04/2018

First Review Completed

Pdp-Amlodipine
For the treatment of mild to moderate essential hypertension and the management of chronic stable angina (effort-associated angina) in patients who remain symptomatic despite adequate doses of beta-blockers and/or organic nitrates or who cannot tolerate those agents

AMLODIPINE BESYLATE
1 mg/mL oral solution

10/01/2023

Active

Quadramet
For the relief of bone pain in patients with multiple osteoblastic skeletal metastases confirmed by positive radionuclide bone scan

samarium Sm 153 lexidronam
50 µCi/mL injection

21/01/2015

Reconsideration Completed

Quinsair
For the management of cystic fibrosis (CF) in patients aged 18 years or older with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections

levofloxacin hemihydrate
240 mg/2.4 mL inhalation solution

20/02/2019

First Review Completed

Retevmo
For the treatment of metastatic RET fusion-positive non-small celllung cancer in adult patients, RET-mutant medullary thyroid cancer in adultand pediatric patients 12 years of age and older with unresectable advancedor metastatic disease, and RET fusion-positive differentiated thyroid carcinoma in adult patients with advanced or metastatic disease (not amenable to surgery or radioactive iodine therapy) following prior treatment with sorafenib and/or lenvatinib

SELPERCATINIB
40 mg and 80 mg capsule

10/05/2022

Active

Radicava
For the treatment of amyotrophic lateral sclerosis (ALS)

EDARAVONE
30 mg / 100 mL IV solution

11/05/2020

First Review Completed

Radicava
For the treatment of amyotrophic lateral sclerosis (ALS)

 

EDARAVONE
30 mg / 100 mL IV solution

11/05/2020

First Review Completed

Radicava
For the treatment of amyotrophic lateral sclerosis

 

EDARAVONE
105 mg/5 mL oral suspension

21/11/2022

Active

Ragwitek
Reducing the signs and symptoms of moderate to severe seasonal short ragweed pollen induced allergic rhinitis

standardized allergen extract, short ragweed (ambrosia artemisiifolia)
12 Amb a 1-U

05/05/2015

First Review Completed

Ragwitek
For the treatment of moderate to severe seasonal short ragweed pollen induced AR, with or without conjunctivitis in children 5 years of age or older.

Standardized Allergen Extract, Short Ragweed (Ambrosia artemisiifolia)
12 Amb a 1-U, sublingual tablet

23/12/2020

Active

Rapaflo
For the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)

silodosin
4 mg and 8 mg capsule

23/04/2013

First Review Completed

Rapid Response Blood Glucose Test Strips
To measure the concentration of glucose in the blood

glucose oxidase

15/06/2018

File Closed

Rapid Response Gluco-MD-Blood Glucose Test Strips
To measure the concentration of glucose in the blood

glucose oxidase

15/11/2019

Active

Rasilez HCT
Mild to moderate essential hypertension

aliskiren fumarate/ hydrochlorothiazide
150 mg/12.5 mg,
150 mg/25 mg,
300 mg/12.5 mg and
300 mg/25 mg tablet

06/07/2011

First Review Completed

Ravicti
For chronic management of adult and pediatric patients ≥ 2 years of age with urea cycle disorders who cannot be managed by dietary protein restriction and/or amino acid supplementation alone

glycerol phenylbutyrate
1.1 g/mL liquid

26/06/2018

First Review Completed

Rebif
Multiple sclerosis (MS)

interferon beta-1a
66 mcg/1.5 mL and 132 mcg/1.5mL prefilled multidose cartridges

01/03/2010

First Review Completed

Rebif
For the treatment of clinically isolated syndrome (CIS) of multiple sclerosis

interferon beta-1a
44 mcg/0.5 mL and 132 mcg/1.5 mL (44 mcg x 3) pre-filled syringe

24/06/2015

First Review Completed

Reblozyl
The treatment of adult patients with transfusion-dependent anemia requiring at least two RBC units over 8 weeks resulting from very low- to intermediate risk myelodysplastic syndromes (MDS) who have ring sideroblasts and who have failed or are not suitable for erythropoietin-based therapy

luspatercept
25 mg/vial and 75 mg/vial, subcutaneous powder for solution

09/04/2021

Active

REDESCA and REDESCA HP
– The prophylaxis of thromboembolic disorders (deep vein thrombosis) in patients undergoing: - orthopedic surgery of the hip or knee; In addition, REDESCA is indicated in hospital or after hospital discharge for long-term prevention of venous thromboembolic diseases following hip replacement surgery. - high risk abdominal, gynecological, or urological surgeries - colorectal surgery
– The prophylaxis of deep vein thrombosis (DVT) in medical patients who are at moderate risk of DVT and who are bedridden due to moderate to severe acute cardiac insufficiency (NYHA Class III or IV heart failure), acute respiratory failure revealing or complicating chronic respiratory insufficiency not requiring ventilatory support and acute respiratory infections (excluding septic shock), who require short-term prophylaxis of deep vein thrombosis.
– The prevention of thrombus formation in the extra-corporeal circulation during hemodialysis.
– The treatment of deep vein thrombosis, with or without pulmonary embolism.
– The treatment of unstable angina or non-Q-wave myocardial infarction, concurrently with ASA.
– Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI)

enoxaparin sodium
100 mg/mL, 150 mg/mL PFS, Vial

30/04/2021

First Review Completed

Relaxa
For the treatment of occasional constipation in adults

polyethylene glycol 3350
510 g powder for suspension

17/08/2012

Withdrawn

Relenza
Influenza A and B infection

zanamivir
5 mg/blister powder for inhalation

01/03/2010

First Review Completed

Relistor
Constipation, Opioid-Induced

methylnaltrexone bromide
20 mg/mL solution

10/07/2009

First Review Completed

Renagel
For the treatment of patients with severe renal impairment when a calcium salt is clinically contraindicated or does not provide optimal control of hyperphosphatemia.

sevelamer HCl
800 mg tablet

29/02/2016

First Review Completed

Renflexis
For the treatment of Rheumatoid Arthritis (Adult), Ankylosing Spondylitis, Crohn's Disease (Adult, Pediatric), Fistulising Crohn's Disease (Adult), Ulcerative Colitis (Adult, Pediatric), Psoriatic Arthritis, and Plaque Psoriasis (Adult)

infliximab
100 mg/vial powder for solution

20/09/2018

First Review Completed

Renvela
For the treatment of hyperphosphatemia according to clinical criteria.

sevelamer carbonate
800 mg tablet and powder for oral suspension 0.8 g and 2.4 g sachets

07/06/2021

First Review Completed

Repatha
As adjunctive therapy to lower low density lipoprotein cholesterol (LDL-C)

evolocumab
140 mg/mL (140 mg/1.0 mL) solution (subcutaneous)

15/06/2018

First Review Completed

Repatha
For the treatment of patients as an adjunct to diet and maximally tolerated statin therapy in adult patients with clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C).

evolocumab
140 mg/mL (140 mg/1.0 mL) solution (subcutaneous)

28/05/2018

Active

Repatha
As an adjunct to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH)

evolocumab
120 mg/mL solution for subcutaneous injection

15/06/2018

First Review Completed

Resotran
For the treatment of chronic idiopathic constipation in adult female patients in whom laxatives failed to provide adequate relief

prucalopride succinate
1 mg and 2 mg FC tablet

22/10/2012

First Review Completed

Restasis
Treatment of moderate to moderately severe aqueous deficient dry

cyclosporine
0.05% w/v ophthalmic emulsion

27/11/2013

Reconsideration Completed

Retin-A Micro
For topical application in the treatment of acne vulgaris

tretinoin
0.1 % microsphere gel and 0.04 % microsphere gel (50 g pump)

06/11/2020

Active

Revestive
For the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support

teduglutide
5 mg per vial

23/01/2019

First Review Completed

Revestive
For the ongoing treatment of patients between 1 and 17 years of age with Short Bowel Syndrome (SBS) who are dependent on parenteral support according to clinical criteria.

teduglutide
5 mg powder for solution for injection

06/04/2021

First Review Completed

Revlimid
Multiple myeloma in patients who have received at least one prior therapy

lenalidomide
5 mg, 10 mg, 15 mg and 25 mg capsule

21/08/2009

First Review Completed

Revlimid
As maintenance treatment of newly diagnosed multiple myeloma patients after stem-cell transplantation

lenalidomide
5 mg, 10 mg, 15 mg and 25 mg capsule

29/02/2016

First Review Completed

Revlimid
For the treatment of newly diagnosed multiple myeloma patients who are not candidate for stem cell transplantation

lenalidomide
5 mg, 10 mg, 15 mg and 25 mg capsule

26/06/2018

First Review Completed

Revlimid
For the treatment of multiple myeloma in combination with dexamethasone for patients who are not candidate for autologous stem cell transplant

lenalidomide
20 mg capsule

26/06/2018

First Review Completed

Revlimid
Newly diagnosed multiple myeloma patients who are not eligible for transplant

lenalidomide
2.5 mg tablet

22/11/2018

First Review Completed

Revlimid
For the treatment of multiple myeloma in transplant ineligible patients according to clinical criteria.

lenalidomide
2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsules

16/12/2020

First Review Completed

Revolade
For adult chronic immune (idiopathic) thrombocytopenic purpura

eltrombopag olamine
25 mg and 50 mg tablet

17/04/2013

Reconsideration Completed

Revolade
To increase platelet counts in thrombocytopenic patients with chronic hepatitis C virus (HCV) infection to allow the initiation and maintenance of interferon-based therapy.

eltrombopag olamine
25 mg and 50 mg tablet

30/07/2015

First Review Completed

Rexulti
For the treatment of schizophrenia in adults.

brexpiprazole
0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg tablet

23/04/2019

First Review Completed

Riabni
For the treatment of various cancer indications according to clinical criteria.

rituximab
10 mg/mL intravenous infusion

15/03/2022

First Review Completed

Rightest Blood Glucose Monitoring System GAI Test Strips
To measure the concentration of glucose in the blood

glucose oxidase

30/11/2015

File Closed

Rituxan
Relapsed chronic lymphocytic leukemia

rituximab
10 mg/mL injection

29/01/2015

Reconsideration Completed

Rituxan
Previously untreated chronic lymphocytic leukemia

rituximab
10 mg/mL injection

02/07/2010

First Review Completed

Rituxan SC
CD20 positive, diffuse large B-cell non-Hodgkin’s lymphoma; follicular non-Hodgkin’s lymphoma

rituximab
120 mg/mL (1400 mg/ 11.7 mL) solution (subcutaneous)

26/06/2018

First Review Completed

Rituxan SC
CD20 positive, diffuse large B-cell non-Hodgkin’s lymphoma; follicular non-Hodgkin’s lymphoma

rituximab
120 mg/mL (1400 mg/ 11.7 mL) solution (subcutaneous)

26/06/2018

First Review Completed

Rituxan SC
For the treatment of chronic lymphocytic leukemia (CLL)

rituximab
120 mg/mL solution for subcutaneous injection (1600 mg/13.4 mL) single dose vial

21/03/2019

First Review Completed

Rituxan; Rituxan SC
Rituxan/Rituxan SC for the treatment with salvage chemotherapy for relapsed/refractory aggressive histology CD20+ lymphoma with intent to proceed to stem cell transplant

rituximab; rituximab SC
10 mg/mL solution for IV administration and 120 mg/mL solution SC

20/09/2019

Active

Riximyo
For the treatment of Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) according to clinical criteria.

rituximab
100 mg/10 mL and 500 mg/ 50mL intravenous solution

04/08/2020

First Review Completed

Riximyo
In combination with glucocorticoids for the induction of remission in adult patients with severely active Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).

RITUXIMAB
10 mg/ mL injection solution

31/08/2021

First Review Completed

Rosiver
For the topical treatment of inflammatory lesions (papules and pustules) of rosacea in adults 18 years of age or older

ivermectin
1% topical cream

29/02/2016

Active

Rovamycine 250mg capsule
Treatment of infections due to susceptible organism

spiramycin
750000 I.U.

26/06/2018

File Closed

Rozlytrek
For the treatment of patients with ROS1-positive, locally advanced or metastatic non-small cell lung cancer.

entrectinib
100 mg and 200 mg capsules

23/12/2022

First Review Completed

Rozlytrek
For the treatment of adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options.

entrectinib
100 mg and 200 mg capsules

15/03/2022

Active

Ruxience
For the treatment of Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) according to clinical criteria.

rituximab
10 mg/mL intravenous solution

04/08/2020

First Review Completed

Ruzurgi
For the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older.

AMIFAMPRIDINE
10 mg tablet

23/02/2021

Active

Rybelsus
For the treatment of adult patients with type 2 diabetes to improve glycemic control:
– in combination with metformin, and
– in combination with metformin and sulfonylurea

semaglutide
3 mg, 7 mg and 14 mg tablets

01/06/2021

Active

Rinvoq
The treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when use of those therapies is inadvisable.

UPADACITINIB
15 mg and 30 mg oral tablet

03/03/2022

Active

Rinvoq
For the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other DMARDs.

UPADACITINIB
15 mg ER tablets

25/03/2022

Active

Rinvoq
For the treatment of moderately to severely active Rheumatoid Arthritis (RA)

UPADACITINIB
15 mg ER tablets

31/10/2022

First Review Completed

Rinvoq
For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or a biologic agent (i.e., tumour necrosis factor-alpha [TNFα] antagonists, integrin receptor antagonists or interleukin 12/23 inhibitors)

 

UPADACITINIB
15 mg, 30 mg and 45 mg extended-release tablets

12/12/2022

Active

Rinvoq
For the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate

UPADACITINIB
15 mg ER tablets

16/11/2022

First Review Completed

Rydapt
For the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 gene mutation positive in combination with standard induction and consolidation chemotherapy

midostaurin
25 mg capsule

22/11/2018

First Review Completed

Rydapt
For the treatment of adult patients with aggressive systemic mastocytosis (AsM) systemic mastocystosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia (MCL) known collectively as advanced systemic Mastocysistic (advSM).

midostaurin
25 mg capsule

08/10/2019

Active

Rylaze
As a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 year or older who have developed hypersensitivity to E. coli-derived asparaginase

CRISANTASPASE RECOMBINANT
10 mg/0.5 mL solution (IM injection)

13/12/2022

Active

Saizen
Growth hormone deficiency

somatropin
6 mg/cartridge (5.83 mg/mL), 12 mg/cartridge (8 mg/mL) and 20 mg/cartridge (8 mg/mL)

18/01/2012

First Review Completed

Samsca
For the treatment of clinically important, non-hypovolemic hyponatremia

tolvaptan
15 mg, 30 mg and 60 mg tablet

28/01/2014

Second Review Completed

Sanctura XR
Overactive bladder

trospium chloride
60 mg capsule

29/04/2011

First Review Completed

Saphnelo
In addition to standard therapy for the treatment of adult patients with active, autoantibody positive, systemic lupus erythematosus.

ANIFROLUMAB
300 mg/2 mL solution for infusion single-use vial

06/06/2022

Active

Santyl
For the debridement of dermal ulcer or severely burned areas

collagenase
250 unit/g topical ointment

19/09/2013

Reconsideration Completed

Saphris
Treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder

asenapine
5 mg and 10 mg tablet

20/02/2014

Second Review Completed

Sarclisa
In combination with pomalidomide and dexamethasone, for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

isatuximab
100 mg/5 mL and 500 mg/ 25mL (20 mg/mL) IV solution for infusion

06/11/2020

Active

Simlandi
Biological Response Modifier

ADALIMUMAB
40 mg / 0.4 mL & 80 mg / 0.8 mL, SC Solution

31/05/2022

First Review Completed

Semglee
Type 1 or Type 2 Diabetes Mellitus (>17 years of age) For once-daily subcutaneous administration in the treatment of patients over 17 years of age with Type 1 or Type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.
• Type 1 Diabetes Mellitus (>6 years of age) In the treatment of pediatric patients (˃6 years old) with Type 1 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia

INSULIN GLARGINE
100 units/mL solution for subcutaneous injection, pre-filled pen

21/12/2022

First Review Completed

Tavalisse
For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments

FOSTAMATINIB
100 mg and 150 mg tablet

31/01/2022

Active

Sarclisa
In combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

ISATUXIMAB
100 mg/5 mL (20 mg/mL) and 500 mg/25 mL IV solution

02/03/2022

Active

Saxenda
Saxenda as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients who have been diagnosed with:
– Obesity (BMI ≥30 kg/m2) AND prediabetes, or
– Overweight (BMI ≥27 kg/m2 and <30 kg/m2) with one or more weight-related comorbidity AND prediabetes.

LIRAGLUTIDE
6 mg / mL SC solution

01/06/2021

Active

Scemblix
For the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase previously treated with two or more tyrosine kinase inhibitors

ASCIMINIB
20 mg and 40 mg tablet

14/09/2022

Active

Seebri Breezhaler
A long-term maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema

glycopyrronium bromide
50 mcg capsule for inhalation

22/08/2013

First Review Completed

Segluromet
– Added on to metformin for patients who have inadequate glycemic control on metformin and have a contraindication or intolerance to a sulfonylurea, or
– To replace the individual components of ertugliflozin and metformin for those patients who are on both therapies.

ertugliflozin and metformin HCl
2.5 mg/ 500 mg, 2.5 mg/ 1000 mg, 7.5 mg/ 500 mg, and 7.5 mg/ 1000 mg tablets

02/11/2018

Active

Seroquel XR
Schizophrenia

quetiapine fumarate
150 mg ER tablet

07/01/2011

First Review Completed

Signifor
For the treatment of patients with Cushing’s disease

pasireotide diaspartate
0.3 mg/ mL, 0.6 mg/ mL and 0.9 mg/ mL subcutaneous solution

04/08/2015

First Review Completed

Siliq
For the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy

brodalumab
210 mg/1.5 mL, sub-cutaneous injection, pre-filled syringe

23/04/2019

First Review Completed

Silkis
Antipsoriatic agent

calcitriol
3 mcg/g topical ointment

26/07/2011

First Review Completed

Simbrinza
Elevated Intraocular Pressure Therapy

brinzolamide & brimonidine tartrate
1.0% w/v & 0.2% w/v ophthalmic suspension

30/11/2015

First Review Completed

Simponi
Rheumatoid arthritis

golimumab
50 mg/ 0.5 mL solution

07/12/2010

First Review Completed

Simponi
Psoriatic arthritis

golimumab
50 mg/ 0.5 mL solution

07/01/2011

First Review Completed

Simponi
Ankylosing spondylitis

golimumab
50 mg/0.5 mL solution

07/01/2011

First Review Completed

Simponi
For the treatment of patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, or have medical contraindications for, conventional therapy

golimumab
50 mg/ 0.5 mL and 100 mg/ 1.0 mL pre-filled syringe and autoinjector

30/11/2015

First Review Completed

Simponi I.V.
Treatment of moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)

golimumab
50 mg/4 mL solution for infusion

30/11/2015

First Review Completed

Skyrizi
For the treatment of moderate to severe plaque psoriasis

RISANKIZUMAB
75 mg in 0.83 mL (90 mg/ mL) SC solution for injection

31/01/2020

First Review Completed

Skyrizi
For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy

RISANKIZUMAB
150 mg/mL 1 mL single use prefilled syringe and 150 mg/mL 1mL single use prefilled pen

31/10/2022

First Review Completed

SMOFlipid
For supply of energy and essential fatty acids and omega-3 fatty acids to adult patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated

soybean oil, medium chain triglycerides,
olive oil and fish oil
6%/ 6%/ 5%/ 3% w/v
injectable emulsion

22/03/2018

First Review Completed

Soliqua
As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) alone or in combination with metformin.

Insulin glargine and Lixisenatide
100 units/mL & 33 mcg/mL solution for injection in a prefilled pen for subcutaneous injection (3mL prefilled pen)

20/12/2019

First Review Completed

Soliris
Paroxysmal nocturnal hemoglobinuria (PNH)

eculizumab
10 mg/mL solution

08/09/2011

Second Review Completed

Soliris
For the treatment of patients with atypical hemolytic uremic syndrome (atypical HUS) to reduce complement-mediated thrombotic microangiopathy

eculizumab
10 mg/mL solution

30/11/2015

Second Review Completed

Soliris
For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. SOLIRIS is not intended for acute treatment of an NMOSD relapse

eculizumab
10 mg/ mL IV solution

19/08/2020

Active

Soliris
In adult patients with generalized Myasthenia Gravis (gMG).

eculizumab
10 mg/ mL IV solution

19/08/2020

Active

Somavert
For the treatment of acromegaly in patients who have had an inadequate response to surgery, and/or radiation therapy or for whom these therapies are not appropriate

pegvisomant
25 mg and 30mg powder for solution

02/03/2018

Active

Sovaldi
Treatment of chronic hepatitis C virus (CHC) infection in adult patients with compensated liver disease, including cirrhosis, as follows: (1) For the treatment of genotype 1 and genotype 4 CHC infection in combination with pegylated interferon and ribavirin; (2) For the treatment of genotype 2 and genotype 3 CHC infection in combination with ribavirin

sofosbuvir
400 mg tablet

25/02/2015

First Review Completed

Spinraza
For the treatment of Type 1 spinal muscular atrophy (SMA) according to clinical criteria.

nusinersen sodium
2.4 mg/mL solution for intrathecal injection

22/11/2018

First Review Completed

Spinraza
Expanded Indication: To include adult type II & type III Spinal Muscular Atrophy (SMA) patients older than 18 years of age regardless of ambulatory status

nusinersen sodium
2.4 mg/mL solution for intrathecal injection

17/03/2022

Active

Spirit Blood Glucose Test Strips
To measure the concentration of glucose in the blood

glucose oxidase

26/06/2018

First Review Completed

Spiriva Respimat
Long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and for the reduction of exacerbations

tiotropium bromide monohydrate
2.5 mcg per actuation, solution for inhalation

31/05/2016

First Review Completed

Spravato
In combination with a SSRI or SNRI, for the treatment of major depressive disorder in adults who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode.

esketamine hydrochloride
28 mg/ ACT nasal solution

28/07/2020

Active

Sprycel
For the treatment of adults with newly diagnosed chronic myeloid leukemia in chronic phase

dasatinib
100 mg tablet

27/03/2012

First Review Completed

Stalevo
Parkinson’s Disease

carbidopa/ levodopa/ entacapone
75 mg and 125 mg tablet

03/11/2010

First Review Completed

Stalevo
Parkinson’s Disease

carbidopa/ levodopa/ entacapone
50 mg, 100 mg and 150 mg tablet

25/02/2009

First Review Completed

Statstrip Xpress Glucose Test Strips
To measure the concentration of glucose in the blood.

Enzyme, Amperometric Glucose Enzyme
(Aspergillus sp., >1.0 IU)

11/10/2018

Active

Steglatro
– As monotherapy for patients who have inadequate glycemic control and for whom metformin or a sulfonylurea is inappropriate due to contraindications or intolerance.
– Add-on to metformin for patients who have inadequate glycemic control on metformin and have a contraindication or intolerance to a sulfonylurea.

ertugliflozin
5 mg and 15 mg tablets

01/11/2018

Active

Stelara
Psoriasis

ustekinumab
45 mg/ 0.5 mL solution

20/09/2010

First Review Completed

Stelara
Psoriasis

ustekinumab
90 mg/ 1mL pre-filled syringe

28/11/2013

First Review Completed

Stelara
For the treatment of moderate to severe Psoriatic Arthritis

ustekinumab
45 mg/0.5 mL and
90 mg/1 mL subcutaneous solution

24/02/2015

First Review Completed

Stelara
For the treatment of adult patients with moderately to severely active Crohn’s disease, who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFα) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids

ustekinumab
90 mg/ mL pre-filled syringe and
130 mg/26 mL single-use vial

29/05/2017

Active

Stelara
For the treatment of adult patients with moderately to severely active ulcerative colitis (UC)

ustekinumab
130 mg/26 mL,
Solution for Subcutaneous Injection 90 mg/1.0 mL,
Solution for Intravenous Infusion

30/07/2020

Active

Stivarga
Treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy

regorafenib
40 mg tablet

02/05/2014

First Review Completed

Stivarga
Treatment of adult patients with metastatic and/or unresectable gastrointestinal stromal tumors who have had disease progression on or intolerance to imatinib mesylate and sunitinib malate treatment

regorafenib
40 mg tablet

29/09/2014

First Review Completed

Stivarga
For the treatment of patients with ECOG status of </=1 and with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-based chemotherapy, an oxaliplatin, irinotecan, an anti-VEGF therapy and, if KRAS wild type, an anti-EGFR therapy

regorafenib
40 mg tablet

30/11/2015

First Review Completed

Stivarga
Treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib

regorafenib
40 mg tablet

20/09/2019

First Review Completed

Stramucin
Topically for the treatment of secondarily infected traumatic lesions such as small lacerations, suture wounds or abrasions.

mupirocin
2% w/w cream

30/09/2020

First Review Completed

Strensiq
Enzyme replacement therapy for patients with confirmed diagnosis of paediatric-onset hypophosphatasia (HPP)

asfotase alfa
40 mg/mL and 100 mg/mL
solution for injection

25/06/2018

First Review Completed

Stribild
As a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve adult patients aged 18 years and older

elvitegravir/ cobicistat/ emtricitabine/
tenofovir disoproxil fumarate
150 mg/ 150 mg/
200 mg/ 300 mg tablet

30/11/2015

First Review Completed

Sublinox
Short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings

zolpidem tartrate
5 mg and 10 mg orally disintegrating tablet

27/05/2014

Reconsideration Completed

Sublocade
For the management of moderate to severe opioid use disorder as a part of a complete treatment plan that includes counselling and psychosocial support in adult patients according to specific criteria.

buprenorphine
100 mg/ 0.5mL and 300 mg/ 1.5mL
subcutaneous, solution ER

30/04/2020

First Review Completed

Suboxone
For substitution treatment in adults with problematic opioid drug dependence

buprenorphine/naloxone
12 mg/3 mg and 16 mg/4 mg
sublingual tablets

06/03/2018

Active

Suboxone
For substitution treatment in adults with problematic opioid drug dependence.

buprenorphine/naloxone
2 mg/ 0.5 mg, 8 mg/ 2 mg and
12 mg/ 3 mg soluble film

31/08/2020

Active

Sunvepra
Treatment of chronic Hepatitis C infections in combination with other drugs

asunaprevir
100 mg capsule

26/06/2018

File Closed

Suretest Blood Glucose Test strips
To measure the concentration of glucose in the blood

glucose oxidase

05/05/2015

First Review Completed

Sutent
For the treatment of patients with unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumor (pNET)

sunitinib malate
12.5 mg, 25 mg and 50 mg capsule

15/10/2013

First Review Completed

Sylvant
For the treatment of patients with Multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV)-negative and human herpes virus-8 (HHV-8)-negative.

siltuximab
100 mg/ vial, 400 mg/ vial lyophilized powder for injection

28/03/2017

First Review Completed

Symtuza
For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years or older with body weight at least 40 kg) and with no known mutations associated with resistance to the individual components of SYMTUZA.

darunavir/ cobicistat/ emtricitabine & tenofovir alafenamide
800 mg/ 150 mg/ 200 mg/ 10 mg
film-coated tablets

20/07/2018

Active

Synjardy
As an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus inadequately controlled on:
– metformin;
– sulfonylurea in combination with metformin;
– pioglitazone in combination with metformin;
– insulin in combination with metformin; OR in patients already being treated and achieving glycemic control with:
– metformin and empagliflozin as separate tablets;
– sulfonylurea in combination with metformin and empagliflozin as separate tablets;
– pioglitazone in combination with metformin and empagliflozin as separate tablets;
– insulin in combination with metformin and empagliflozin as separate tablets

empagliflozin & metformin HCl
5 mg & 500 mg,
5 mg & 850 mg,
5 mg & 1000 mg,
12.5 mg & 500 mg,
12.5 mg & 850 mg and
12.5 mg & 1000 mg
FC tablet

24/10/2018

First Review Completed

Tafinlar
For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation

dabrafenib mesylate
50 mg and 75 mg capsule

21/08/2014

First Review Completed

Tafinlar
In combination with Mekinist (trametinib), for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph node(s), following complete resection.

dabrafenib mesylate
50 mg and 75 mg capsule

07/01/2020

First Review Completed

Tafinlar & Mekinist
For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation

dabrafenib mesylate & trametinib dimethyl sulfoxide
50 mg, 75 mg capsule &
0.5 mg, 2 mg tablet

26/06/2018

First Review Completed

Tafinlar & Mekinist
In combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation whose disease has progressed following systemic therapy

dabrafenib mesylate & trametinib dimethyl sulfoxide
50 mg, 75 mg capsule &
0.5 mg, 2 mg tablet

26/06/2018

First Review Completed

Tafinlar & Mekinist
TAFINLAR and MEKINIST in combination for the treatment of patients with metastatic NSCLC with a BRAF V600 mutation and who have not received any prior anti-cancer therapy for metastatic disease.

dabrafenib mesylate & trametinib dimethyl sulfoxide
50 mg, 75 mg capsule &
0.5 mg, 2 mg tablet

19/03/2021

Active

Tagrisso
Treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer who have progressed on or after EGFR tyrosine kinase inhibitor therapy

OSIMERTINIB
40 mg and 80 mg tablet

22/11/2018

First Review Completed

Tagrisso
For the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations).

OSIMERTINIB
40 mg and 80 mg tablet

10/01/2020

First Review Completed

Tagrisso
As adjuvant therapy after tumour resection in patients with stage IB-IIIAi non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations

OSIMERTINIB
40 mg and 80 mg tablet

15/11/2022

First Review Completed

Takhzyro
For the routine prevention of attacks of hereditary angioedema (HAE) according to clinical criteria.

lanadelumab
150 mg/mL solution in a
single-use vial subcutaneous injection

02/02/2021

First Review Completed

Takhzyro
For the routine prevention of attacks of hereditary angioedema (HAE) according to clinical criteria.

lanadelumab
300 mg /2 mL solution for SC injection

14/01/2022

First Review Completed

Taltz
For the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

ixekizumab
80 mg/mL solution (subcutaneous) pre-filled auto-injector and 80 mg/mL solution (subcutaneous) pre-filled syringe

22/03/2018

First Review Completed

Taltz
For the treatment of adult patients with active psoriatic arthritis who have responded inadequately to, or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDS).

ixekizumab
80 mg/ mL pre-filled autoinjector and syringe

21/03/2019

First Review Completed

Taltz
For the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to, or are intolerant to conventional therapy.

ixekizumab
80 mg/ mL prefilled autoinjector and
80 mg/ mL prefilled syringe

21/02/2020

Active

Tamiflu
Antiviral agent

oseltamivir phosphate
30 mg and 45 mg capsule

21/03/2011

First Review Completed

Tamiflu
Antiviral agent

oseltamivir phosphate
6 mg/mL powder for suspension

25/09/2012

File Closed

Tapazole
For the treatment of hyperthyroidism

methimazole
5 mg tablet

30/07/2015

First Review Completed

Tezspire
As an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma

TEZEPELUMAB
110 mg/mL SC solution

06/09/2022

Active

Tepmetko
For the treatment of adult patients with locally advanced unresectable or metastatic non small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET)tyrosine kinase receptor exon 14 skipping alterations.

TEPOTINIB
225 mg oral tablet

31/01/2022

Active

Tarceva
Treatment of non-small cell lung cancer in the first-line maintenance setting

erlotinib
25 mg, 100 mg and
150 mg tablet

20/10/2011

First Review Completed

Targin
Relief of pain and opioid induced constipation

oxycodone hydrochloride/naloxone hydrochloride
10/5 mg, 20/10 mg and
40/20 mg CR tablet

22/10/2012

Second Review Completed

Tasigna
For the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase

nilotinib
200 mg capsule

26/07/2011

Reconsideration Completed

Tasigna
For the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase

nilotinib
150 mg capsule

17/04/2012

First Review Completed

Tykess Blood Glucose Test Strips
To measure the concentration of glucose in the blood.

GLUCOSE OXIDASE (A. Niger)
10% Test Strip

14/03/2022

Active

Taxotere
Early stage breast cancer

docetaxel
20 mg/ 0.5 mL and
80 mg/ 2.0 mL solution

04/10/2010

File Closed

Tecentriq
In combination with nab-paclitaxel for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 and who have not received prior chemotherapy for metastatic disease. Maintenance TECENTRIQ + nab-paclitaxel should be continued until disease progression or unacceptable toxicity.

atezolizumab
1200 mg/ 12 mL vial

28/10/2019

Active

Tecentriq
For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or after systemic chemotherapy, until loss of clinical benefit

atezolizumab
1200 mg/ 12 mL vial

20/12/2019

First Review Completed

Tecentriq
For the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC) in combination with a platinum-based chemotherapy and etoposide. Maintenance Tecentriq should be continued until loss of clinical benefit or unacceptable toxicity.

atezolizumab
1200 mg/ 12 mL vial

28/08/2019

Active

Tecentriq and Avastin
In combination with AVASTIN (bevacizumab), for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who require systemic therapy.

atezolizumab
1200 mg/20 mL (60mg/mL) and 25 mg/mL (100 mg/4mL & 400 mg/16 mL) concentrate for solution for infusion

15/03/2022

First Review Completed

Tecentriq
Monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after cytotoxic chemotherapy until unacceptable toxicity or confirmed disease progression.

atezolizumab
840 mg /14 mL Intravenous solution, concentrate, single use vials

12/01/2022

First Review Completed

Tecentriq
First-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide.

atezolizumab
1200 mg/20 mL (60 mg/mL) solution

02/03/2022

Active

Tecentriq
Tecentriq in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive stage small cell lung cancer.

atezolizumab
1200 mg/ 12 mL vial

04/11/2019

Active

Tecentriq and Avastin
In combination with AVASTIN (bevacizumab), for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who require systemic therapy.

atezolizumab
1200 mg/20 mL (60mg/mL) and
25 mg/mL (100 mg/4mL & 400 mg/16 mL)
concentrate for solution for infusion

18/12/2020

Active

Tecfidera
As monotherapy for the treatment of relapsing remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of disability

dimethyl fumarate
120 mg DR capsule

27/05/2014

First Review Completed

Tecfidera
As monotherapy for the treatment of relapsing remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of disability

dimethyl fumarate
240 mg DR capsule

12/12/2014

First Review Completed

Technivie
Treatment of adults with genotype 4 chronic hepatitis C virus infection without cirrhosis who are either treatment naïve or previously treated with peginterferon and ribavirin.

ombitasvir/ paritaprevir/
ritonavir
12.5 mg/ 75 mg/ 50 mg tablet

31/03/2016

Active

Tecta
Conditions where a reduction of gastric acid secretion is required

pantoprazole magnesium
40 mg EC tablet

30/06/2010

First Review Completed

Tegsedi
For the treatment of polyneuropathy in patients with hereditary transthyretin-mediated amyloidosis (hATTR) according to clinical criteria.

inotersen
284 mg inotersen / 1.5 mL per syringe
[189 mg inotersen / mL
(as inotersen sodium)]
solution for injection

20/07/2020

First Review Completed

Trodelvy
For adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two therapies, including at least one prior therapy for unresectable locally advanced or metastatic disease.

SACITUZUMAB GOVITECAN
180 mg/vial IV, powder for solution

01/11/2021

Active

TBC
For the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to, or are intolerant of, a C5 inhibitor

PEGCETACOPLAN
54 mg/mL solution (SC infusion)

04/01/2023

Active

Ultomiris
For the treatment of adult patients with paroxysmal nocturnal hemoglobinuria
(PNH)

RAVULIZUMAB
10 mg/mL IV solution

23/12/2021

Active

Ultomiris
For the treatment of adults and pediatric patients with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy

RAVULIZUMAB
10 mg/mL IV solution

06/12/2022

Active

Ultomiris
For the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized Myasthenia Gravis (gMG)

RAVULIZUMAB
10 mg/mL solution (IV infusion)

06/01/2023

Active

Vabysmo
For the treatment of diabetic macular edema (DME)

FARICIMAB
6 mg/0.05 mL solution for intravitreal injection

04/08/2022

Active

Vabysmo
For the treatment of neovascular (wet) age-related macular degeneration (AMD)

FARICIMAB
6 mg/0.05 mL solution for intravitreal injection

02/08/2022

Active

Vyepti
For the prevention of migraine in adults who have at least 4 migraine days per month

EPTINEZUMAB
100 mg/mL IV solution

15/09/2022

Active

Vegzelma

Metastatic Colorectal Cancer (mCRC)

Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Malignant Glioma (WHO Grade IV) - Glioblastoma

BEVACIZUMAB
100 mg/4 mL & 400 mg/16 mL vial solution for injection

16/01/2023

Active

Verquvo
To reduce the risk of cardiovascular death and heart failure (HF) hospitalization, in adults with symptomatic chronic HF and ejection fraction less than 45% who are stabilized after a recent worsening HF event

VERICIGUAT
2.5 mg, 5 mg and 10 mg tablet

03/02/2023

Active

Temodal
Newly diagnosed glioblastoma multiforme. Recurrent or progressive glioblastoma multiforme or anaplastic astrocytoma

temozolomide
140 mg and 180 mg capsule

08/09/2011

First Review Completed

Thalomid
For treatment of previously untreated multiple myeloma in patients who are 65 years of age and older

thalidomide
50 mg capsule

19/10/2012

First Review Completed

Tivicay
For the treatment of human immunodeficiency virus (HIV)

dolutegravir sodium
50 mg tablet

05/05/2015

First Review Completed

TOBI PODHALER
For the management of cystic fibrosis (CF) patients aged 6 years or older with chronic pulmonary Pseudomonas aeruginosa infections

tobramycin
28 mg capsule (tobramycin inhalation powder for oral inhalation only)

30/05/2012

Second Review Completed

TOBI PODHALER
Is indicated for the management of cystic fibrosis (CF) patients aged 6 years or older with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections

tobramycin
28 mg capsule
(tobramycin inhalation powder for
oral inhalation only)

06/07/2016

First Review Completed

Toctino
For the treatment of severe chronic hand eczema refractory to high potency topical corticosteroids in adults

alitretinoin
10 mg and 30 mg soft capsule

23/04/2013

Reconsideration Completed

TOUJEO DoubleSTAR
For once-daily subcutaneous administration in the treatment of adult patients (≥18 years) with Type 1 or Type 2 diabetes mellitus who require basal (long-acting) insulin for glycemic control

insulin glargine
300 U/mL (900 U/3 mL) prefilled pen

30/09/2020

First Review Completed

TOUJEO SoloSTAR
Treatment of adult patients (≥18 years) with Type 1 or Type 2 diabetes mellitus who require basal (long-acting) insulin for glycemic control

insulin glargine
300 unit/mL
[1.5mL (450IU) prefilled pen]
subcutaneous solution

20/09/2018

First Review Completed

Toviaz
For the treatment of patients with overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence, or any combination of these symptoms

fesoterodine fumarate
4 mg and 8 mg tablet

23/04/2013

First Review Completed

TRADENAME
For the treatment of moderately to severely active Rheumatoid Arthritis (RA)

upadacitinib
15 mg extended-release tablets

18/11/2019

Active

Trajenta
For treatment in adults patients with type 2 diabetes mellitus to improve glycemic control

linagliptin
5 mg tablet

21/09/2012

First Review Completed

Travatan Z
Intraocular pressure

travoprost
0.0004% w/v ophthalmic solution

21/08/2009

First Review Completed

Trazimera
For the treatment of breast and gastric cancers, according to clinical criteria

TRASTUZUMAB
440 mg lyophilized powder per vial and
150 mg lyophilized powder per vial

15/11/2019

First Review Completed

Trazimera
Metastatic Breast Cancer

TRASTUZUMAB
440 mg/vial and 150 mg/vial IV,
powder for solution

15/09/2022

First Review Completed

Treanda
Relapsed indolent B-cell non-Hodgkin lymphoma (NHL) who did not respond to or progressed during or shortly following treatment with a rituximab regimen

bendamustine hydrochloride
25 mg/ vial and 100 mg/ vial

31/05/2013

First Review Completed

Treanda
Symptomatic chronic lymphocytic leukemia (CLL) who have received no prior treatment First line treatment of indolent non-Hodgkin lymphoma and mantle cell lymphoma

bendamustine hydrochloride
25 mg/ vial and 100 mg/ vial

31/05/2013

First Review Completed

Treanda
In combination with rituximab (BR) for treatment of previously untreated CLL patients

bendamustine hydrochloride
25 mg/8 mL and 100 mg/20 mL
lyophilized powder for
IV injection single use vials

26/06/2018

First Review Completed

Trelegy Ellipta
For the long-term, once daily, maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

fluticasone furoate & umeclidiunium
62.5 mg & 25 mg, dry powder inhaler

20/09/2019

First Review Completed

Trelstar
The palliative treatment of hormone dependent advanced carcinoma of the prostate gland

triptorelin pamoate
22.5 mg powder for suspension,
sustained-release

21/11/2014

First Review Completed

Tremfya
For the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy

GUSELKUMAB
100 mg/mL solution,
prefilled syringe

06/03/2018

Active

Tremfya
For the treatment of adult patients with active psoriatic arthritis. Can be used alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate)

GUSELKUMAB
100 mg/mL SC solution & 100 mg/mL patient controlled injector (SC solution)

02/09/2022

Active

Tresiba
For once-daily treatment of adults with diabetes mellitus to improve glycemic control

insulin degludec
100 unit/mL and 200 unit/mL
SC solution flextouch prefilled pen

20/09/2018

First Review Completed

Tresiba (Penfill)
For once-daily treatment of adults with diabetes mellitus to improve glycemic control

insulin degludec
100 unit/mL solution (SC injection)

25/01/2023

Active

Triamcinolone Hexacetonide Injectable Suspension
For intra-articular, intrasynovial, or periarticular use in adults and adolescents for the symptomatic treatment of subacute and chronic inflammatory joint diseases including:
– Rheumatoid arthritis
– Juvenile Idiopathic Arthritis (JIA)
– Osteoarthritis and post-traumatic arthritis
– Synovitis, tendinitis, bursitis and epicondylitis

triamcinolone hexacetonide
20 mg/mL suspension,
Intra-Articular/ Periarticular/
Intrasynovial Injection

28/05/2019

Active

Trikafta
For the treatment of cystic fibrosis in patients who meet clinical criteria.

elexacaftor/ ivacaftor/
ivacaftor/ tezacaftor
100 mg/ 150 mg/
75 mg/ 50 mg

22/09/2021

First Review Completed

Trikafta
For the treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene

ELEXACAFTOR/TEZACAFTOR/IVACAFTOR AND IVACAFTOR
50 mg/25 mg /37.5 mg and 75 mg tablet

08/07/2022

First Review Completed

Trintellix
For the treatment of major depressive disorder (MDD) in adults

vortioxetine hydrobromide
5 mg, 10 mg and 20 mg tablet

04/08/2015

File Closed

Trintellix
For the treatment of major depressive disorder (MDD) in adults

vortioxetine hydrobromide
5 mg, 10 mg and 20 mg tablet

29/01/2021

First Review Completed

Trisenox
Induction of remission and consolidation in patients with acute promyelocytic leukemia

arsenix trioxide
10mg/10mL (1mg/mL) ampoule

21/08/2014

First Review Completed

Triumeq
Treatment of Human Immunodeficiency Virus (HIV-1) infection in adults

dolutegravir (as dolutegravir sodium)/
abacavir (as abacavir sulfate)/
lamivudine
50 mg/ 600 mg/ 300 mg tablet

24/06/2015

First Review Completed

Truetest Blood Glucose Test Strips
To measure the concentration of glucose in the blood

glucose dehydrogenase – PQQ

07/01/2011

First Review Completed

Trulicity
For the treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control; metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control

dulaglutide
0.75 mg/0.5 mL,
1.5 mg/0.5 mL single use pen,
subcutaneous solution for injection

06/07/2016

Active

Trulicity
For the treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control; metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control

dulaglutide
0.75 mg/0.5 mL,
1.5 mg/0.5 mL single use pen,
subcutaneous solution for injection

06/07/2016

Active

Trurapi
The treatment of patients with diabetes mellitus who require insulin for the control of hyperglycemia. Trurapi should normally be used in regimens together with an intermediate or long-acting insulin

INSULIN ASPART
100 units/mL,
subcutaneous solution for injection

30/09/2021

First Review Completed

Trurapi
• For the treatment of patients with diabetes mellitus who require insulin for the control of hyperglycemia.
• Trurapi should normally be used in regimens together with an intermediate or long-acting insulin.
• Trurapi (10 mL vials) may also be used for continuous subcutaneous insulin infusion (CSII) in pump systems which are licensed in Canada for Trurapi insulin infusion

INSULIN ASPART
100 units/mL vial, solution for subcutaneous injection

24/10/2022

Active

Truvada
For use in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

emtricitabine & tenofovir
disoproxil fumarate
200 mg and 300 mg tablet

21/09/2017

First Review Completed

Truxima
For the treatment of Rheumatoid Arthritis (RA) patients.

rituximab
10 mg/mL Intravenous Infusion,
100 mg (10 mL) or
500 mg (50 mL) single-use vials.

31/03/2020

First Review Completed

Truxima
For the treatment of various cancers according to clinical criteria

rituximab
10 mg/mL Intravenous Infusion,
100 mg (10 mL) or 500 mg (50 mL)
single-use vials.

31/03/2020

First Review Completed

Truxima
In combination with glucocorticoids is indicated for the induction of remission in adult patients with severely active Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).

rituximab
100 mg/10 mL and
500 mg/ 50 mL
solution for intravenous infusion

30/09/2020

First Review Completed

Tukysa
In combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and T-DM1, separately or in combination

TUCATINIB
50 mg and 150 mg tablet

06/10/2022

Active

Tudorza Genuair
Long-term maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema

aclidinium bromide
400 mcg/ actuation

21/08/2014

First Review Completed

Twynsta
For the treatment of mild to moderate essential hypertension where combination therapy is appropriate

telmisartan/ amlodipine besylate
40 mg/5 mg, 40 mg/10 mg,
80 mg/5 mg and
80 mg/10 mg tablet

21/02/2012

First Review Completed

Twynsta, Pre-Notice of Compliance
For the treatment of mild to moderate essential hypertension where combination therapy is appropriate

telmisartan/ amlodipine besylate
40 mg/5 mg, 40 mg/10 mg,
80 mg/5 mg and
80 mg/10 mg tablet

12/08/2011

Withdrawn

Tykerb
Advanced or metastatic breast cancer which overexpress Her2

lapatinib ditosylate
250 mg tablet

04/01/2012

Reconsideration Completed

Tykerb
In combination with letrozole for the treatment of post-menopausal patients with hormone receptor positive metastatic breast cancer, whose tumours overexpress the ErbB2 (HER2) receptor, and who are suitable for endocrine therapy.

lapatinib ditosylate
250 mg tablet

27/11/2013

First Review Completed

Uloric
To lower serum uric acid levels in patients with gout

febuxostat
80 mg tablet

27/03/2012

Reconsideration Completed

Ultibro Breezhaler
For treatment of chronic obstructive pulmonary disease

indacaterol maleate/
glycopyrronium bromide
110 mcg & 50 mcg
inhalation powder hard capsule

24/06/2015

First Review Completed

Unituxin
In combination with granulocyte-macrophage colony stimulating factor (GM-CSF), interleukin-@ (IL-s) and 13 cis-retinoic acid (RA), for the treatment of high-risk neuroblastoma in pediatric patients who achieve at least a partial response to prior first-line multi-agent, multimodality therapy.

dinutuximab
3.5 mg/mL IV solution

26/02/2019

Active

Uptravi
For the long-term treatment of idiopathic pulmonary arterial hypertension (iPAH), heritable pulmonary arterial hypertension (HPAH), PAH associated with connective tissue disorders and PAH associated with congenital heart disease, in adult patients with WHO functional class (FC) II-III to delay disease progression

selexipag
200 mcg, 400 mcg,
600 mcg, 800 mcg,
1000 mcg, 1200 mcg,
1400 mcg and 1600 mcg
FC tablet

26/06/2018

First Review Completed

Vagifem LD
Vaginal atrophy due to estrogen deficiency

estradiol hemihydrate
10 mcg tablet

08/09/2011

First Review Completed

Vectibix
For the treatment of patients with wild-type RAS metastatic colorectal cancer in first line treatment setting in combination with FOLFOX

panitumumab
100 mg/5mL solution for infusion

31/10/2017

First Review Completed

Vectibix
In combination with chemotherapy, for the first-line treatment of mCRC patients with left sided primary tumours that express wild-type RAS

panitumumab
100 mg/5mL and
400 mg/20 mL
(20 mg/mL) solution for infusion

05/03/2018

Active

Velcade
Mantle cell lymphoma, relapsed or refractory to at least one prior therapy

bortezomib
3.5 mg powder for injection

13/05/2009

First Review Completed

Velcade
First – line treatment of multiple myeloma

bortezomib
3.5 mg powder for injection

13/05/2009

First Review Completed

Velcade
Combination therapy in pre-autologous stem cell transplantation (ASCT) and monotherapy in post-ASCT in patients with Multiple Myeloma

bortezomib
3.5 mg powder for injection

30/11/2015

First Review Completed

Velphoro
For the treatment of hyperphosphatemia associated with end-stage renal disease according to clinical criteria.

sucroferric oxyhydroxide
500 mg iron
(equivalent to 2500 mg sucroferric oxyhydroxide)
chewable tablets

26/02/2020

First Review Completed

Vemlidy
Treatment of chronic hepatitis B in adults with compensated liver disease

tenofovir alafenamide hemifumarate
25 mg tablet

06/09/2018

Active

Venclexta
As monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior therapy, or patients with CLL without 17p deletion who have received at least one prior therapy and for whom there are no other available treatment options

venetoclax
10 mg, 50 mg, 100 mg
FC tablet and
10 mg/ 50 mg/ 100 mg
FC tablet, starter kit

02/05/2019

First Review Completed

Venclexta
For the use as monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and who have failed a B-Cell Receptor Inhibitor (BCRi)

venetoclax
10 mg, 50 mg, 100 mg
FC tablet and
10 mg/ 50 mg/ 100 mg
FC tablet, starter kit

16/03/2020

First Review Completed

Venclexta
In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

venetoclax
10 mg, 50 mg, and
100 mg tablets

16/03/2020

First Review Completed

Venclexta
In combination with obinutuzumab for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)

venetoclax
10 mcg, 50 mcg,
100 mcg FC Tablet,
10 mcg/ 50 mg/ 100 mcg
FC Tablet, starter kit

06/05/2022

First Review Completed

Venclexta
In combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

venetoclax
10 mcg, 50 mcg,
100 mcg FC Tablet,
10 mcg/ 50 mg/ 100 mcg
FC Tablet, starter kit

31/05/2021

Active

Verkazia
For the treatment of severe vernal keratoconjunctivitis according to clinical criteria.

cyclosporine
0.1% w/v topical ophthalmic emulsion

03/03/2021

First Review Completed

Verzenio
For the treatment of (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative advanced or metastatic breast cancer: -In combination with an aromatase inhibitor in postmenopausal women as initial endocrine based therapy. -In combination with fulvestrant in women with disease progression following endocrine therapy. Pre- or perimenopausal women must also be treated with a gonadotropin-releasing hormone agonist.

abemaciclib
50 mg, 100 mg and
150mg tablet

24/09/2019

Active

Viacoram
For the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate

perindopril arginine & amlodipine
3.5 mg/2.5 mg, 7 mg & 5 mg and
14 mg & 10 mg tablet

09/03/2017

Active

Viberzi
For the treatment of irritable bowel syndrom (IBS-D) with diarrhea in adults

eluxadoline
75 mg and 100 mg tablets

25/07/2018

Active

Victoza
Treatment of adults with Type 2 diabetes

liraglutide
6 mg/mL solution for injection

30/05/2012

First Review Completed

Victrelis, Pre-Notice of Compliance
Treatment of chronic hepatitis C genotype 1 infection in adult patients

boceprevir
200 mg capsule

04/01/2012

First Review Completed

Vidaza, Pre-Notice of Compliance
Myelodysplastic syndrome

azacitidine
100 mg/vial lyophilized powder

30/06/2010

First Review Completed

Vimizim
Indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis IVA (Morquio A syndrome, or MPS IVA)

elsolfase alfa
1 mg/mL intravenous solution

30/07/2015

First Review Completed

Vimizim
Indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis IVA (Morquio A syndrome, or MPS IVA)

elsolfase alfa
5 mg/5 mL solution
for intravenous infusion

13/06/2016

Active

Vimpat
As adjunctive therapy for adult patients with epilepsy

lacosamide
50 mg, 100 mg, 150 mg and
200 mg FC tablet

01/05/2012

First Review Completed

Viramune XR
Treatment of HIV-1 infection in combination with other antiretroviral agents

nevirapine
400 mg ER tablet

19/07/2012

First Review Completed

Viread
Chronic hepatitis B in adults

tenofovir disoproxil fumarate
300 mg tablet

16/06/2009

First Review Completed

Visanne
For the management of pelvic pain associated with endometriosis

dienogest
2 mg tablet

19/07/2012

First Review Completed

Vitrakvi
For the treatment of adult and pediatric patients with solid tumours that:
– have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation,
– are metastatic or where surgical resection is likely to result in severe morbidity, and
– have no satisfactory treatment options.

larotrectinib sulfate
25 mg and 100 mg capsules,
20 mg/mL oral solution

12/02/2020

Active

Vizimpro
For the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR-activating mutations.

dacomitinib
15 mg, 30 mg, and 45 mg tablets

07/06/2019

Active

Vocabria AND Cabenuva
VOCABRIA (cabotegravir tablets) is indicated, in combination with EDURANT (rilpivirine tablets), as a complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically stable and suppressed (HIV1 RNA less than 50 copies/mL) as:
– an oral lead-in to assess tolerability of cabotegravir prior to initiating CABENUVA
– oral bridging therapy for missed CABENUVA injections CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is indicated:
– as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL).

cabotegravir and cabotegravir and
rilpivirine
30 mg tablet, AND 200 mg/mL /
300 mg/ mL
(400 mg/ 2mL and 600 mg/ 2mL)
Kit, IM, ER injectable suspension,
200 mg/ mL / 300 mg/ mL
(600 mg/ 3mL and 900 mg/ 3mL) Kit,
IM, ER injectable suspension

25/11/2020

Active

Vacabria
In combination with rilpivirine tablets, as a complete regimen for short-term treatment of Human Immunodeficiency Virus-Type 1 (HIV-1) infection in adult patients who are virologically stable and suppressed (defined as HIV-1 ribonucleic acid [RNA] level [viral load] of less than 50 copies/mL) as:
– An oral lead-in to assess tolerability of cabotegravir prior to initiating Cabenuva (cabotegravir/rilpivirine) injections;
– Oral bridging therapy for missed Cabenuva injections; The prescriber must be approved for the Facilitated Access to HIV/AIDS Drug Products mechanism.

cabotegravir
30 mg tablet

30/11/2021

First Review Completed

Volibris
Pulmonary arterial hypertension

ambrisentan
5 mg and 10 mg tablet

26/03/2009

First Review Completed

Vosevi
For the treatment of chronic hepatitis C virus (HCV) infection in adult patients, without cirrhosis or with compensated cirrhosis, who have: - genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor; - genotype 1, 2, 3, or 4 infection and have been previously treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.

sofosbuvir/ velpatasvir/ voxilaprevir
400 mg/ 100 mg/ 100 mg tablet

05/04/2018

First Review Completed

Votrient
The treatment of patients with metastatic renal cell carcinoma

pazopanib hydrochloride
200 mg tablet

23/01/2014

Reconsideration Completed

Votrient
Treatment of advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy

pazopanib hydrochloride
200 mg tablet

22/04/2013

First Review Completed

VPRIV
Long-term enzyme replacement therapy for pediatric and adult patients with type 1 Gaucher disease

velaglucerase alfa
400U/vial powder for
solution for injection

04/01/2012

First Review Completed

Vraylar
Acute management of manic or mixed episodes associated with bipolar I disorder in adults, and the acute management of depressive episodes associated with bipolar I disorder in adults.

CARIPRAZINE
1.5 mg and 3 mg capsule

06/06/2022

Active

Vraylar
For the acute and long-term maintenance treatment of schizophrenia in adults.

CARIPRAZINE
1.5 mg and 3 mg capsule

17/03/2022

Active

Vascepa
To reduce the risk of ischemic cardiovascular events/ death due to cardiovascular event non-fatal myocardial infarction, non-fatal stroke, coronary revascularization and unstable angina) in statin-treated patients, with elevated triglycerides and other risk factors such as established cardiovascular disease or at high risk for cardiovascular disease.

icosapent ethyl
1 g capsule

21/07/2022

First Review Completed

Vyndaqel
For the treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis, wild-type or hereditary, to reduce cardiovascular mortality and cardiovascular-related hospitalization.

tafamidis meglumine
20 mg capsule

15/09/2022

First Review Completed

Vyndamax
For the treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis (ATTR-CM), wild type or hereditary, to reduce cardiovascular mortality and cardiovascular related hospitalization.

tafamadis
61 mg capsule

15/09/2022

First Review Completed

Vyvanse
Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years

lisdexamfetamine dimesylate
30 mg and 50 mg capsule

16/06/2011

First Review Completed

Vyvanse
Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years

lisdexamfetamine dimesylate
20 mg, 40 mg and 60 mg capsule

16/06/2011

First Review Completed

Vyvanse
Attention Deficit Hyperactivity Disorder (ADHD)

lisdexamfetamine dimesylate
10 mg capsule

26/06/2018

First Review Completed

Vyvanse
For the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

lisdexamfetamine dimesylate
10 mg, 20 mg, 30 mg,
40 mg, 50 mg, 60 mg,
chewable tablets (new dosage form)

31/03/2020

First Review Completed

Vyzulta
For the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

latanoprostene bunod
0.024 % / w/v ophthalmic solution

20/12/2019

First Review Completed

Xalkori
Monotherapy for anaplastic lymphoma kinase activated or metastatic non-small cell lung cancer

crizotinib
200 mg and 250 mg capsule

19/09/2013

Reconsideration Completed

Xalkori
Monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC)

crizotinib
200 mg and 250 mg capsule

05/01/2016

First Review Completed

Xamiol
Psoriasis

calcipotriol/ betamethasone
50 mcg/g and
0.5 mg/g topical gel

19/05/2011

First Review Completed

Xarelto
Prevention of venous thromboembolic events (VTE)

rivaroxaban
10 mg FC tablet

25/07/2012

First Review Completed

Xarelto
Prevention of stroke and systemic embolism in patients with atrial fibrillation, in whom anticoagulation is appropriate

rivaroxaban
15 mg and 20 mg FC tablet

25/07/2012

First Review Completed

Xarelto
For the treatment of deep vein thrombosis (DVT) in patients without symptomatic pulmonary embolism

rivaroxaban
15 mg and 20 mg FC tablet

11/12/2012

First Review Completed

Xarelto
For the treatment of pulmonary embolism (PE)

rivaroxaban
15 mg and 20 mg FC tablet

30/11/2015

First Review Completed

Xarelto
Xarelto 2.5 mg FC tablet in combination with 75 mg – 100 mg acetylsalicylic acid (ASA), is indicated for the prevention of stroke, myocardial infarction and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with coronary artery disease (CAD) with or without peripheral artery disease (PAD).

rivaroxaban
2.5 mg FC tablet

20/12/2019

First Review Completed

Xarelto, Pre-Notice of Compliance
Prevention of venous thromboembolic events (VTE)

rivaroxaban
10 mg FC tablet

18/11/2008

File Closed

Xeljanz
In combination with methotrexate for reducing the signs and symptoms of rheumatoid arthritis in adult patients with moderately to severely active RA who have had an inadequate response to methotrexate

tofacitinib citrate
5 mg tablet

28/03/2017

First Review Completed

Xeljanz
Use in combination with methotrexate, for the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease modifying anti-rheumatic drugs (DMARDs) treatment regimens

tofacitinib citrate
11 mg, extended-release oral tablets

30/05/2018

Active

Xeljanz
For the treatment of adult patients with moderately to severely active ulcerative colitis (UC) with an inadequate response, loss of response or intolerance to either conventional UC therapy or a TNFα inhibitor.

tofacitinib citrate
5 mg and 10 mg tablets

30/09/2020

First Review Completed

Xeloda
First-line and second-line treatment of metastatic colorectal cancer

capecitabine
150 mg and 500 mg tablet

05/02/2009

First Review Completed

Xeomin
Symptomatic management of blepharospasm

clostridium botulinum
neurotoxin type A
100LD50 units per vial powder
for solution for injection

19/05/2011

First Review Completed

Xeomin
Symptomatic management of cervical dystonia

clostridium botulinum
neurotoxin type A
100LD50 units per vial powder for
solution for injection

19/05/2011

First Review Completed

Xeomin
Symptomatic management of post-stroke spasticity of the upper limb

clostridium botulinum
neurotoxin type A
100LD50 units per vial powder for
solution for injection

29/03/2012

Reconsideration Completed

Xeomin
For the treatment of hypertonicity disorders

clostridium botulinum
neurotoxin type A
50 LD50 units per vial

28/11/2013

First Review Completed

Xermelo
For the treatment of refractory carcinoid syndrome diarrhea, in combination with somatostatin analogue (SSA) therapy, in patients inadequately controlled by SSA therapy alone.

telotristat etiprate
250 mg tablet

30/01/2019

Active

Xpovio
In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

SELINEXOR
20 mg FC tablets

21/06/2022

Active

Xydalba
For the treatment of adult patients with acute bacterial skin and skin structure infections caused by susceptible isolates of specific gram-positive microorganisms.

DALBAVANCIN HYDROCHLORIDE
500 mg/vial lyophilized powder for solution, intravenous

10/05/2022

Active

Xgeva
Reducing the risk of developing skeletal-related events in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours

denosumab
120 mg/ 1.7 mL solution
in a single-use vial

17/04/2012

First Review Completed

Xiaflex
For the treatment of adult patients with Dupuytren’s contracture with a palpable cord.

collagenase clostridium histolyticum
0.9 mg/vial lyophilized powder for injection

21/01/2015

Reconsideration Completed

Xigduo
Treatment of Type 2 diabetes

dapagliflozin & metformin HCl
5 mg/850 mg and
5 mg/1000 mg tablet

08/08/2017

First Review Completed

Xofigo
For the treatment of patients with castration-resistance prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.

radium RA 223 dichloride
1000 kBq/ mL/
solution for injection

22/01/2015

First Review Completed

Xolair
Moderate to severe asthma

OMALIZUMAB
150 mg powder
for solution for injection

18/01/2012

Reconsideration Completed

Xolair
Treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment

OMALIZUMAB
150 mg powder
for solution for injection

23/05/2017

First Review Completed

Xolair
For the treatment of patients (6 years of age and above) with moderate to severe persistent asthma, who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids, and for the treatment of patients 12 years of age and above with chronic idiopathic urticaria (CIU) who remain symptomatic despite H1 antihistamine treatment

OMALIZUMAB
150 mg powder
for solution for injection

03/11/2021

First Review Completed

Xolair
IgE-Neutralizing Antibody (Anti-IgE)

OMALIZUMAB
75 mg/0.5 mL solution for subcutaneous injection, pre-filled syringe

06/12/2022

Active

Xospata
For the treatment of adult patients diagnosed with relapsed or refractory FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML) according to clinical criteria.

gilteritinib
40 mg tablet

12/01/2021

First Review Completed

Xtandi
For the treatment of patients with metastatic castration-resistant prostate cancer in the setting of medical or surgical castration who have received docetaxel therapy

enzalutamide
40 mg capsule

28/11/2013

First Review Completed

Xtandi
For the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have not received prior chemotherapy.

enzalutamide
40 mg capsule

30/11/2015

First Review Completed

Xtandi
In combination with androgen deprivation therapy (ADT) for the treatment of high risk, nonmetastatic CRPC patients.

enzalutamide
40 mg capsule

10/06/2020

First Review Completed

Xtandi
For the treatment of metastatic castration-sensitive prostate cancer according to clinical criteria.

enzalutamide
40 mg capsule

12/01/2021

First Review Completed

Xultophy
As an adjunct to lifestyle modifications, for the once-daily treatment of adults with type 2 diabetes mellitus to improve glycemic control in combination with metformin, with or without sulfonylurea, when these combined with basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily), do not provide adequate glycemic control.

insulin degludec + liraglutide injection
100 units/mL + 3.6 mg/mL subcutaneous
solution for injection in a pre-filled pen

21/06/2019

Active

Xyrem
Narcolepsy

sodium oxybate
500 mg/mL oral solution

10/07/2009

Reconsideration Completed

YAZ
Oral contraceptive/acne therapy

ethinyl estradiol/ drospirenone
3.0mg / 0.020mg FC tablets

25/09/2009

First Review Completed

Yuflyma
Biological Response Modifier

ADALIMUMAB
100 mg/mL SC solution, prefilled syringe and pre-filled pen (auto-injector)

31/05/2022

First Review Completed

Yuflyma
Biological Response Modifier

ADALIMUMAB
100 mg/mL solution for subcutaneous injection

28/12/2022

Active

Yervoy
For the treatment of unresectable or metastatic melanoma

ipilimumab
5 mg/mL IV solution

24/06/2015

First Review Completed

Yervoy
For the treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic therapy for advanced disease

ipilimumab
5 mg/ mL intravenous infusion

21/09/2012

First Review Completed

Yervoy and Opdivo
OPDIVO (nivolumab) in combination with YERVOY (ipilimumab) and 2 cycles of chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no known EGFR or ALK genomic tumor aberrations.

ipilimumab and nivolumab
5 mg/mL IV solution,
40 mg/ 4mL solution and
100 mg/10mL solution

18/12/2020

Active

Opdivo
In combination with fluoropyrimidine- and platinum containing chemotherapy, is indicated for the treatment of adult patients with HER2 negative advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma.

  • Adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer in patients who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT)

NIVOLUMAB
10 mg/mL (40 mg/4 mL) intravenous solution and 10 mg/mL (100 mg/10 mL) intravenous solution

10/11/2022

First Review Completed

Opdivo and Yervoy
OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.

nivolumab and ipilimumab
40 mg/4 mL (10 mg/mL), 100 mg/10 mL (10 mg/mL) AND 5 mg/mL (50 mg/10 mL), 5 mg/mL (200 mg/40 mL) IV solution

12/05/2022

First Review Completed

Yescarta
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for:
– the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

axicabtagene ciloleucel
200000000 CELLS / BAG

24/07/2020

Active

Yondelis
For the treatment of patients with metastatic liposarcoma or leiomyosarcoma after failure of prior anthracycline and ifosfamide chemotherapy

trabectedin
1 mg/ vial intravenous powder for solution

06/06/2016

Active

Zaltrap
In combination with an irinotecan-fluoropyrimidine-based (FOLFIRI) chemotherapy for patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen

aflibercept
25 mg/ mL IV solution

30/11/2015

File Closed

Zaxine
Reduction in risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age

rifaximin
550 mg tablet

06/07/2016

First Review Completed

Zejula
For the maintenance treatment of newly diagnosed or recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer according to clinical criteria.

niraparib
100 mg capsules

21/12/2021

First Review Completed

Zejula
Monotherapy for the maintenance treatment of adult patients with advanced epithelial ovarian cancer are in a complete or partial response to first-line platinum-based chemotherapy.

niraparib
100 mg capsules

08/04/2021

Active

Zelboraf
For the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma

vemurafenib
240 mg tablet

30/11/2015

Reconsideration Completed

Zenhale
For the treatment of asthma, in patients 12 years of age and older with reversible obstructive airway disease

mometasone furoate/ formoterol
50mcg/ 5mcg, 100mcg/ 5mcg and
200mcg/ 5mcg
metered dose inhaler

21/02/2012

First Review Completed

Zepatier
For the treatment of Chronic Hepatitis C (CHC) genotypes 1, 3, or 4 infections in adults

elbasvir & grazoprevir
50 mg & 100 mg tablet

26/06/2018

First Review Completed

Zeposia
For the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations.

ozanimod HCl
0.92 mg gelatin capsule, 0.23 mg/ 0.46 mg gelatin capsule (kit)

06/11/2020

Active

Wakix
For the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.

PITOLISANT HCl
5 mg and 20 mg tablet

10/03/2022

Active

Wegovy
As an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, or obstructive sleep apnea.

SEMAGLUTIDE
0.25 mg/pen, 0.5 mg/pen, 1 mg/pen, 1.7 mg/pen, 2.4 mg/pen, 1 mg/pen, 2 mg/pen, 4 mg/pen, 6.8 mg/pen & 9.6 mg/pen SC pre-filled pen

10/08/2022

Active

Waymade-Trientine
For the treatment of patients with Wilson's Disease who are intolerant to penicillamine.

TRIENTINE HYDROCHLORIDE
250 mg capsule

11/08/2022

First Review Completed

Zepzelca
For the treatment of adult patients with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after platinum-containing therapy.

LURBINECTEDIN
4 mg per vial (0.5 mg/mL) IV, powder for solution

20/05/2022

Active

Zeulide Depot
For the palliative treatment of advanced and/or metastatic prostate cancer.

leuprolide acetate
3.75 mg [1-Month] and
22.5 mg [3-Month],
Intramuscular Injection.

04/11/2019

Active

Ziextenxo
To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

pegfilgrastim
6 mg (10 mg/ml), sterile solution
for injection

28/08/2020

First Review Completed

Zinbryta
For the treatment of adult patients with active relapsing remitting multiple sclerosis (RRMS) who have had an inadequate response to, or who are unable to tolerate, one or more therapies indicated for the treatment of multiple sclerosis (MS).

daclizumab beta
150 mg/mL solution
for injection

08/08/2017

Active

Zirabev
For the treatment of various cancers, according to clinical criteria.

bevacizumab
100 mg (25 mg/mL solution for injection) and 400 mg (25 mg/mL solution for injection) intravenous solution.

31/10/2019

First Review Completed

Zolgensma
For the treatment of spinal muscular atrophy (SMA) in patients who meet clinical criteria.

onasemnogene abeparvovec
2 x 1013 vector genomes/mL, solution for intravenous infusion

29/10/2021

First Review Completed

Zometa
Bone metastases due to renal cell carcinoma (mRCC)

zoledronic acid
4 mg/5 mL solution

04/10/2010

First Review Completed

Zometa
Adjuvant treatment of hormone receptor-positive early breast cancer in pre-menopausal women

zoledronic acid
4 mg/5 mL solution

04/10/2010

First Review Completed

Zometa
For the treatment of patients with osteolytic lesions of multiple myeloma

zoledronic acid
4 mg/5 mL solution

31/07/2013

First Review Completed

Zyclara
Treatment of actinic keratoses

imiquimod
3.75% topical cream

05/12/2012

Withdrawn

Zydelig
In combination with rituximab for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL)

idelalisib
100 mg and 150 mg tablet

28/03/2017

First Review Completed

Zydelig
As a monotherapy for the treatment of patients with follicular lymphoma (FL) who have received at least two prior systemic regimens and are refractory to both rituximab and an alkylating agent

idelalisib
100 mg and 150 mg tablet

03/11/2016

File Closed

Zykadia
As monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib

ceritinib
150 mg capsules

04/03/2016

First Review Completed

Zykadia
As monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib

ceritinib
150 mg capsules

22/11/2018

First Review Completed

Zytiga
In combination with prednisone for the treatment of metastatic prostate cancer (castration-resistant prostate cancer) in patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy

abiraterone acetate
250 mg tablet

30/11/2015

First Review Completed

Zytiga
For the treatment of metastatic castrate-resistant prostate cancer (mCRPC)

abiraterone acetate
500 mg FC tablet

06/06/2017

First Review Completed

Zytiga, Pre-Notice of Compliance
For the treatment of metastatic prostate cancer in patients who have received prior chemotherapy

abiraterone acetate
250 mg tablet

04/01/2012

First Review Completed

 

 


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