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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
2mg, 5mg, 10mg, 15mg, 20mg and 30mg tablet
19/10/2011 First Review Completed
Abilify
For major depressive disorder
aripiprazole
2mg, 5mg, 10mg, 15mg, 20mg and 30mg tablets
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, sustained-release (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
100mg/vial
30/06/2011 Reconsideration Completed
Abraxane
Metastatic pancreatic cancer
nab-paclitaxel
100mg/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/4mL) 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
100mg/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
100mcg, 200mcg, 300mcg, 400mcg, 600mcg and 800mcg sublingual tablet
03/04/2012 First Review Completed
Accel-Sevelamer
For the treatment of hyperphosphatemia according to clinical criteria.
sevelamer carbonate
800mg 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
80mg/4mL, 200mg/10mL and 400mg/20mL intravenous solution
23/01/2014 Reconsideration Completed
Actemra
Polyarticular Juvenile Idiopathic Arthritis (pJIA)
tocilizumab
20mg/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
162mg/0.9mL subcutaneous solution
27/10/2015 First Review Completed
Actemra
For the treatment of giant cell arteritis (GCA) in adult patients
tocilizumab
162mg/0.9mL 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 syringes
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
150mg tablet
16/06/2009 First Review Completed
Actonel DR
Treatment and prevention of osteoporosis
risedronate sodium
35mg 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
20mg/81mg, 30mg/81mg and 60mg/81mg
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
50mg lyophilized powder
20/02/2014 First Review Completed
Adcetris
For the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen
brentuximab vedotin
50mg 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
50mg 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
50mg 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
50mg 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
50mg 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
20mg 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
0.5mg, 1mg, 1.5mg, 2mg, 2.5mg 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
0.5mg, 1mg, 1.5mg, 2mg, and 2.5mg 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
0.05mg/mL (10mcg/dose),
0.1mg/mL (20mcg/dose)
single-use pre-filled pen,
0.05mg/mL & 0.1mg/mL
(10mcg/dose & 20mcg/dose)
starter kit SC solution
20/12/2019 First Review Completed
Admelog
Anti-Diabetic Agent
insulin lispro
100units/mL solution for injection
18/12/2020 First Review Completed
Advagraf
Prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants
tacrolimus
3mg 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
10mg 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
2.5mg, 5mg and 10mg tablet
27/10/2015 First Review Completed
Afinitor
The treatment of Subependymal Giant Cell Astrocytoma (SEGA) associated with Tuberous Sclerosis Complex
everolimus
2.5mg, 5mg and 10mg 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
2.5mg, 5mg and 10mg 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
2.5mg, 5mg and 10mg 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
300mg & 0.5mg 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
100mg/vial
01/03/2010 First Review Completed
Alimta
First-line treatment of non-small cell lung cancer
pemetrexed
500mg/vial
10/07/2009 First Review Completed
Alimta
Maintenance treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer
pemetrexed
100mg/vial and 500mg/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
100mg/500mg 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
0.5mg capsule
29/08/2013 First Review Completed
Aloxi
Prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy
palonosetron
0.5mg 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
50mg/mL solution for SC injecton, prefilled syringe and autoinjector
29/03/2021 First Review Completed
Androderm
Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism)
testosterone
24.3mg 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
100U/mL injection solution – 10mL vial and 3mL pack
21/08/2009 First Review Completed
Apidra
Diabetes, Type 1 & 2
insulin glulisine
100U/mL solution – 3mL 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
200mg/ 400mg / 600mg / 800mg tablet
25/11/2015 First Review Completed
Arbesda
For the treatment asthma in patients aged 12 years and older.
fluticasone propionate & salmeterol
55mcg/ 14mcg, 113mcg/ 14mcg, and 232/ 14mcg, 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/30mg (1.5mL) 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
200mcg and 400mcg 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
100mcg/ metered inhalation
27/10/2015 Active
Atacand
Hypertension
candesartan cilexetil
32mg tablet
20/05/2009 First Review Completed
Atacand Plus
Hypertension
candesartan cilexetil/hydrochlorothiazide
32mg/12.5mg and 32mg/25mg 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
14mg tablet
24/11/2014 First Review Completed
Avastin
Metastatic breast cancer
bevacizumab
100mg/4mL vial and 400mg/ 16mL vial IV solution
05/07/2011 Reconsideration Completed
Avastin
Advanced metastatic or recurrent non-squamous non-small cell lung cancer
bevacizumab
100mg/4mL vial and 400mg/ 16mL vial IV solution
30/06/2010 First Review Completed
Avastin
For treatment of patients with recurrent glioblastoma multiforme (GBM)
bevacizumab
100mg/ 4mL SD Vial (25mg/ mL) and 400mg/ 16mL (25mg/ 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
25mg/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
25mg/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 autoinject 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/30mg (1.5mL) 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
100mg/4mL, 400mg/16mL Inj 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)
182mcg/5.8mcg/ 8.2mcg 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
100mg, 200mg and 400mg 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
20mg/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
120mg/ vial and 400mg/ 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
200mg in 1mL solution for SC injection
30/09/2019 Active
Benylsta
In addition to standard therapy for reducing disease activity in adult patients with active autoantibody positive systemic Lupus Erythematosus (SLE).
benlimumab
200mg in 1mL solution for SC injection
15/11/2019 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
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 (3mg/dose), nasal powder – intranasal – single use
31/01/2022 First Review Completed
Besponsa
Treatment of relapsed or refractory (R/R) B-Cell precursor acute lymphoblastic Leukemia (ALL)
inotuzumab ozogamicin
1mg 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
0.3mg/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
38.5mcg/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
100mg and 500mg 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
Braftovi AND Mektovi
BRAFTOVI and MEKTOVI in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
encorafenib and binimetinib
75 mg capsule and 15 mg tablets
04/04/2021 Active
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
100mcg/25mcg 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
100mcg/25mcg & 200mcg/25mcg, 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
60mg tablet
28/03/2017 Active
Brilinta, Pre-Notice of Compliance
Prevention of thrombotic events in patients with Acute Coronary Syndromes
ticagrelor
90mg 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
5mcg/hr, 10mcg/hr and 20mcg/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
2.5mg, 5mg, 10mg and 20mg tablet
18/07/2014 Reconsideration Completed

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
200mg/mL & 300mg/mL Inj 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 capsules
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 capsules
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
0.5mg / 1.5mg per vial
16/01/2014 First Review Completed
Cayston
Management of cystic fibrosis (CF) patients with chronic pulmonary Pseudomonas aeruginosa infections
aztreonam
75mg/vial powder for solution
21/09/2012 First Review Completed
Celsentri
Treatment experienced patients infected with HIV
maraviroc
150mg and 300mg tablet
25/02/2009 First Review Completed
Celsentri
For treatment naïve HIV-infection
maraviroc
150mg and 300mg tablet
05/10/2011 First Review Completed
Cesamet
Management of nausea and vomiting associated with cancer therapy
nabilone
0.25mg capsule
10/07/2009 First Review Completed
Cimzia
Moderate to severe active rheumatoid arthritis (RA)
certolizumab pegol
200mg/mL pre-filled syringe
01/10/2010 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
For reducing signs and symptoms in adult patients with active ankylosing spondylitis
certolizumab pegol
200mg/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
200mg/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
200mg/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
10mg and 20mg 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
20mcg/100mcg 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
200mg/25mg/300mg 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 tablets
03/04/2020 Active
Calquence
Monotherapy for patients with chronic lymphocytic leukemia (CLL) who have received at least one therapy.
acalabrutinib
100 mg capsules
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 capsules
03/12/2021 First Review Completed
Copaxone
Clinically Isolated Syndrome (CIS), after a first demyelinating event
glatiramer acetate
20mg/1mL 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
8mg/2.5mg 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 capsules
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
500mg/10mL 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
500mg/10mL 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
10mg/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
Daklinza
Treatment of chronic Hepatitis C infections in combination with other agents
dalatasvir
30mg and 60mg 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
100mg/5mL and 400mg/20mL 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
100mg/5mL and 400mg/20mL 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
100mg/5 mL and 400mg/20mL 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
100mg/5 mL and 400mg/20mL 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 tablets
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
25/03/2022 Active
Daxas
Maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis
roflumilast
500mcg film-coated tablet
17/05/2012 Reconsideration Completed
DDAVP MELT
Central diabetes insipidus and primary nocturnal enuresis
desmopressin acetate
240mcg 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
10mg and 15mg 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
250mg and 500mg capsule
30/07/2015 First Review Completed
Diamicron MR
Diabetes mellitus
gliclazide
60mg 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
320mg/12.5mg and 320mg/25mg 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
50mcg/g / 0.5mg/g topical gel
27/05/2014 First Review Completed
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
20mg/mL and 5mg/mL intraintestinal gel
23/06/2014 Reconsideration Completed
DuoTrav
Ocular hypertension and open-angle glaucoma
travoprost/timolol maleate
0.004% and 0.5% ophthalmic solution - 5mL bottle
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/1.14mL 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 pre-filled pen, solution for subcutaneous injection in 2mL pre filled 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
Duragesic Mat
Opioid analgesic
fentanyl
25mcg/hr, 50mcg/hr, 75mcg/hr and 100mcg/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
50mcg & 137mcg (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
40mg and 80mg 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
40mg/12.5mg, 80mg/12.5mg and 40mg/25mg tablet
25/03/2014 First Review Completed
Edurant
Treatment of HIV-1 infection in antiretroviral treatment-naïve adult patients
rilpivirine hydrochloride
25mg 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
10mg 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
1mg/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
2.5mg and 5mg 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
2.5mg FC tablet
24/11/2015 First Review Completed
Eliquis
Prevention of stroke and systemic embolism in patients with atrial fibrillation
apixaban
2.5mg and 5mg tablet
22/08/2013 First Review Completed
Eloxatin
Metastatic colorectal cancer
oxaliplatin
50mg/10mL, 100mg/20mL and 200mg/40mL solution
05/07/2011 First Review Completed
Eloxatin
As part of the FOLFIRINOX regimen for the treatment of metastatic pancreatic cancer
oxaliplatin
50mg/10mL, 100mg/20mL and 200mg/40mL solution
04/01/2012 First Review Completed
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
50mg/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
300mg/vial powder for solution
20/04/2017 First Review Completed
Entyvio
For patients with moderately to severely active Crohn’s disease (CD)
vedolizumab
300mg/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
10mg, 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
2mg/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
2mg/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, 50mg/mL prefilled syringe, and 25mg/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/0.5mL solution for injecton 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
50mg/ 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/0.5mL solution for injecton 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
150mg 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
267mg 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
0.3mg/vial powder for solution
21/03/2011 First Review Completed
Eylea
For the treatment of neovascular (wet) age-related macular degeneration (AMD)
aflibercept
40mg/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
40mg/mL/solution for intravitreal injection
04/08/2015 First Review Completed
Eylea
Treatment of diabetic macular edema
aflibercept
40mg/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
2mg 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
10mg SR tablet
20/09/2013 Second Review Completed
Fampyra
Symptomatic improvement of walking in adult patients with multiple sclerosis with walking disability
fampridine
10mg 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
50mg/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
50mg/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
1000mg 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
100mg/mL oral solution
15/06/2018 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 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
5mg 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
5mg 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
10mg/mL SC solution
24/11/2015 First Review Completed
Firmagon
Advanced hormone-dependent prostate cancer
degarelix acetate
80mg/vial and 120mg/vial powder for solution
21/03/2011 First Review Completed
Fluanxol Depot
Schizophrenia
flupenthixol decanoate
20mg/mL solution in 1mL ampoule and 100mg/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
10mg 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 controlled release capsules
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 controlled release capsule
08/08/2022 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
250mcg/mL injection
27/05/2014 Reconsideration Completed
Forxiga
For use in patients with type 2 diabetes mellitus to improve glycemic control
dapagliflozin
5mg and 10mg 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
5mg and 10mg 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
5mg and 10mg tablet
17/12/2021 First Review Completed
Fosavance
Osteoporosis in postmenopausal women and osteoporosis in men
alendronate sodium/cholecalciferol
70mg/140µg tablet
16/06/2009 First Review Completed
Fragmin
Anticoagulation
dalteparin sodium
7500IU/0.3mL 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
2mg, 4mg, 6mg, 8mg, 10mg and 12mg tablet
20/02/2014 First Review Completed
Fycompa
As an adjunctive therapy for the management of primary generalized tonic-clonic seizures in adults
perampanel
2mg, 4mg, 6mg, 8mg, 10mg and 12mg 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
150mg 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
25mg/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
25mg/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
100mg/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
5.3mg and 12mg pre-filled pen, GoQuick 0.6mg, 0.8mg, 1mg, 1.2mg, 1.4mg, 1.6mg, 1.8mg and 2mg 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
5.3mg and 12mg pre-filled pen, GoQuick 0.6mg, 0.8mg, 1mg, 1.2mg, 1.4mg, 1.6mg, 1.8mg and 2mg 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
5.3mg and 12mg pre-filled pen, GoQuick 0.6mg, 0.8mg, 1mg, 1.2mg, 1.4mg, 1.6mg, 1.8mg and 2mg 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
150mg & 150mg & 200mg & 10mg 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
0.5mg 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
20mg, 30mg and 40mg 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
100mg and 400mg tablet
27/04/2012 Reconsideration Completed
Glucagen, Glucagen Hypokit
Treatment of severe hypoglycemic reaction
glucagon
1mg/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
90mg/400mg 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
3.75mg/ 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
440mg/ vial/ 20mL/ 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
440mg/ 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)
HERZUMA 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 andcyclophosphamide, in combination with paclitaxel or docetaxel
  • in combination with adjuvant chemotherapy consisting of docetaxel andcarboplatin.

Metastatic Breast Cancer (MBC)
HERZUMA is indicated for the treatment of patients with MBC whose tumours overexpress HER2.

Metastatic Gastric Cancer (MGC)
HERZUMA 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.

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
200U/mL solution
25/06/2018 First Review Completed
Humalog KwikPen, Humalog Mix25 KwikPen, Humalog Mix50 KwikPen
Diabetes, Type 1 & 2
insulin lispro
100U/mL, 25%/ 75% and 50%/ 50% prefilled pen
19/05/2011 First Review Completed
Humira
For treatment of fistulizing Crohn’s
adalimumab
40mg/0.8mL 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
40mg/ 0.8mL vial for pediatric use, 40mg/ 0.8mL pre-filled syringe and 40mg/ 0.8mL pre-filled pen
20/02/2014 First Review Completed
Humira
For ulcerative colitis
adalimumab
40mg/ 0.8mL subcutaneous solution
29/03/2016 File Closed
Humira
For the treatment of non-infections uveitis
adalimumab
40mg/ 0.8mL 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
40mg/0.8mL 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
40mg/ 0.8mL 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
4.5mg and 9mg 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
40mg/ 0.8mL and 20mg/0.4mL 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
400mg and 600mg tablet
05/05/2015 First Review Completed
Ibavyr
In combination with other agents for the treatment of chronic hepatitis C (CHC) in adults
ribavirin
200mg 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
75mg, 100mg and 125mg 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
15mg and 45mg 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
150mg powder for solution
25/08/2016 Active
Ilaris
For the ongoing management of Cryopyrin-Associated Periodic Syndromes
canakinumab
150mg powder for solution - single use vials
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
6.5mg vaginal ovule
02/02/2022 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
140mg capsule
04/08/2015 First Review Completed
Imbruvica
For the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL)
ibrutinib
140mg capsule
25/06/2018 First Review Completed
Imbruvica
Treatment of Waldenström’s Macroglobulinemia (WM)
ibrutinib
140mg 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
140mg 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
Incivek
Treatment of genotype 1 chronic hepatitis C
telaprevir
375mg 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
30mg/0.3mL, 40mg/0.4mL, 60mg/0.6mL, 80mg/0.8mL and 100mg/mL AND 120mg/0.8mL and 150mg/mL solution for injecton
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
100mg/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)
62.5mcg 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
100mg/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
100mg/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
1mg and 5mg 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/0.25mL 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
2.5mcg/2.5mcg per actuation, inhalation solution
15/06/2018 First Review Completed
Inspra
Post myocardial infarction
eplerenone
25mg and 50mg tablet
29/04/2010 First Review Completed
Inspra
Heart failure, NYHA class ll
eplerenone
25mg and 50mg 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
200mg 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
1mg, 2mg, 3mg and 4mg ER tablet
22/01/2015 First Review Completed
Intuniv XR
For the treatment of attention deficit hyperactivity disorder, according to specified criteria
guanfacine hydrochloride
1mg, 2mg, 3mg and 4mg ER tablet
31/01/2020 First Review Completed
Invega Sustenna
Schizophrenia
paliperidone palmitate
50mg/0.5mL, 75mg/0.75mL, 100mg/1mL and 150mg/1.5mL ER suspension
18/01/2012 First Review Completed
Invega Trinza
Treatment of schizophrenia in adult patients
paliperidone (supplied as paliperidone palmitate)
175mg/0.875mL, 263mg/1.315mL, 350mg/1.75mL, 525mg/ 2.625mL suspension (extended-release; intramuscular) prefilled syringe
22/03/2018 First Review Completed
Invokamet
Type 2 diabetes
canagliflozin & metformin HCl
50mg/500mg, 50mg/850mg, 50mg/1000mg, 150mg/500mg, 150mg/850mg and 150mg/1000mg 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
100mg and 300mg tablet
04/08/2015 First Review Completed
Iressa
First-line treatment for locally advanced or metastatic non-small cell lung cancer
gefitinib
250mg tablet
19/10/2011 Reconsideration Completed
Isentress
As part of a HIV treatment regimen for treatment-naive adult patients
raltegravir potassium
400mg 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
90mg, 180mg and 360mg 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
10mg 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
5mg, 15mg and 20mg 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
5mg, 10mg, 15mg, 20mg tablet
25/06/2018 First Review Completed
Jakavi
For the treatment of graft-versus-host disease (GvHD) in patients aged 12 years and older who have inadequate response to corticosteroids or other systemic therapies.
ruxolitinib
5mg, 10mg, 15mg, 20mg tablet
08/03/2022 Active
Janumet
Diabetes, Type 2
sitagliptin/metformin hydrochloride
500mg/50mg, 850mg/50mg and 1000mg/50mg tablet
17/02/2012 First Review Completed
Janumet XR
Diabetes, Type 2
sitagliptin phosphate monohydrate and metformin hydrochloride
50mg/1000mg 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
25mg and 50mg tablet
19/09/2013 First Review Completed
Jardiance
To improve glycemic control in adult patients with type 2 diabetes mellitus
empagliflozin
10mg and 25mg tablet
30/05/2016 First Review Completed
Jardiance
Add-on combination in patients with established cardiovascular disease
empagliflozin
10mg and 25mg 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
40mg/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
45mg+15mg, 60mg+30mg, 90mg+30mg 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
50mg and 25mg tablet
23/04/2019 First Review Completed
Jurnista
Moderate to severe chronic pain
hydromorphone hydrochloride
4mg, 8mg, 16mg and 32mg 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)
5mg, 10mg, 20mg 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
100mg/160mg 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
100mg/25mg tablet
26/03/2009 First Review Completed
Kalydeco
For the treatment of cystic in patients age 6years and older according to clinical criteria
ivacaftor
150mg 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
150mg 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
150mg 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
08/08/2022 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 injecton, 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
50mg/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
50mg/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 100mg/4mL 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/4mL 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/4mL 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/4mL 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/4mL 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
100mcg/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
100mg/4mL 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
100mg/4mL 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
100mg/4mL 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
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
Komboglyze
Type 2 diabetes mellitus
saxagliptin HCl / metformin HCl
2.5mg/500mg, 2.5mg/850mg and 2.5mg/1000mg tablet
12/12/2014 First Review Completed
Kuvan
BH4-responsive Phenylketonuria (PKU)
sapropterin dihydrochloride
100mg 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
60mg 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
60mg 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 3mL 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
6mg, 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
40mg, 80mg and 120mg 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
20mg and 60mg 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

29/08/2022 Active
Lemtrada
For the management of adult patients with relapsing remitting multiple sclerosis
alemtuzumab
12mg/1.2mL 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
12mg/1.2mL 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
10mg, 14mg, 20mg and 24mg 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
10mg, 14mg, 20mg and 24mg 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
100unit/mL solution for injection
02/05/2014 First Review Completed
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
350mg/7mL (50mg/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
350mg/7mL (50mg/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
3.75g/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
10mg/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
10mg/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
10mg/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
100mg and 150mg 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
100mg and 150mg 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
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
30mg/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
100mg/40mg 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) 01/03/2022 Active
Mekinist
For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation
trametinib
0.5mg and 2mg 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)
10mg/0.2mL, 12.5mg/0.25ml 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)
15mg/0.3mL solution (subcutaneous) single-use pre-filled syringe
30/04/2019 First Review Completed
Metvix
Superficial basal cell carcinoma
methyl aminolevulinate
168mg/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
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
3g 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
400mg 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
4.5mg 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
25mg and 50mg 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 25mg tablet
04/08/2015 First Review Completed
Neupogen
Primary prophylaxis of febrile neutropenia
filgrastim
300mcg/mL vial and 480mcg/1.6mL injection
04/10/2010 First Review Completed
Neupogen
Primary prophylaxis of febrile neutropenia
filgrastim
300mcg/mL vial and 480mcg/1.6mL 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
300mcg/mL vial and 480mcg/1.6mL 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
2mg/24hr, 4mg/24hr, 6mg/24hr and 8mg/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
2mg/24h, 4mg/24h, 6mg/24h, 8mg/24h transdermal system patch
31/10/2017 First Review Completed
Nexavar
Metastatic renal cell carcinoma
sorafenib tosylate
200mg 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
200mg 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
30mg 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
25mg 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
5mg/1.5mL, 10mg/1.5mL and 15mg/1.5mL subcutaneous solution
04/08/2015 First Review Completed
Norditropin SimpleXx
Growth disturbance in children born small for gestational age
SOMATROPIN
5mg/1.5mL, 10mg/1.5mL and 15mg/1.5mL solution
04/08/2015 First Review Completed
Norditropin SimpleXx
Growth failure in children due to growth hormone deficiency
SOMATROPIN
5mg/1.5mL, 10mg/1.5mL and 15mg/1.5mL 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
100mg 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
250mcg/0.5mL and 500mcg/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
300mg tablet
08/06/2021 First Review Completed
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
50mg, 100mg, 150mg, 200mg, and 250mg extended-release tablets
30/01/2019 Active
Nucynta CR
For the management of moderate to moderately severe pain in adults
tapentadol
50mg, 100mg, 150mg, 200mg and 250mg 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
5mg/2mL/20mg/2mL 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
10mg/2mL 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
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
100mg and 150mg 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
20mg and 40mg tablet
29/04/2010 First Review Completed
Olmetec Plus
Hypertension
olmesartan medoxomil/hydrochlorothiazide
20mg/12.5mg, 40mg/12.5mg and 40mg/25mg 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 Solution for Injection Pre-filled Syringe
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
50mcg nasal spray
25/09/2009 First Review Completed
Omnitrope
Growth hormone deficiency in children and adults
somatropin
5.8mg/vial solution
17/11/2010 First Review Completed
Omnitrope
Growth hormone deficiency in children and adults
somatropin
15mg/1.5mL solution for injection
02/03/2018 Active
Onbrez Breezhaler
For treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)
indacaterol maleate
75mcg 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
5mg tablet
21/02/2012 Reconsideration Completed
Onglyza
Diabetes, Type 2
saxagliptin
2.5mg 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
4.3mg/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
200mcg, 400mcg, 600mcg, 800mcg and 1200mcg 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)
ONTRUZANT (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)
ONTRUZANT is indicated for the treatment of patients with MBC whose tumours overexpress HER2.
The benefits of treatment with ONTRUZANT in patients who do not overexpress HER2 (HER2 overexpression 0 as determined by a validated immunohistochemical (IHC) test or who exhibit lower-level overexpression (HER2 overexpression 1+ as determined by a validated IHC test, and the subgroup of patients with HER2 overexpression 2+ as determined by a validated IHC test that corresponds to 1+ scoring by the investigative clinical trial assay), are unclear.
ONTRUZANT 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. For information on the use of ONTRUZANT in combination with PERJETA and docetaxel, consult the Product Monograph for PERJETA.

Metastatic Gastric Cancer (MGC)
ONTRUZANT 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.

ONTRUZANT should only be administered to patients with MGC whose tumours have HER2 overexpression as defined by IHC2+ confirmed by Fluorescent In Situ Hybridization (FISH+), or IHC 3+ as determined by an accurate and validated assay
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
40mg/4mL and 100mg/10mL solution
31/03/2017 First Review Completed
Opdivo
For advanced or metastatic renal cell carcinoma who have received prior anti-angiogenic treatment
nivolumab
40mg/4mL and 100mg/10mL 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
40mg/4mL 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
40mg/4mL and 100mg/10mL 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
40mg/4mL, 100mg/10mL single-use vials and 5mg/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
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.
nivolumab
10 mg/mL (40 mg/ 4 mL) IV solution, and 10mg/ mL (100mg/ 10mL) IV solution
02/12/2021 Active
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
40mg/4mL (10 mg/mL), 100mg/10mL (10 mg/mL) AND 5mg/mL (50mg/10mL), 5mg/mL (200 mg/40mL) IV solution
12/05/2022 First Review Completed
Opdivo and Yervoy
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
40mg/4mL (10 mg/mL), 100mg/10mL (10 mg/mL) AND 5mg/mL (50mg/10mL), 5mg/mL (200 mg/40mL) 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
40mg/4mL, 100mg/10mL single-use vials and 5mg/mL vials
23/04/2019 First Review Completed
Opsumit
For the treatment of patients with pulmonary arterial hypertension according to clinical criteria
macitentan
10mg 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
250mg/15mLvial 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
4mg/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
10mg, 20mg and 30mg 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
10mg, 20mg, 30mg (tablet (starter pack kit) and 30mg tablet
31/03/2016 Active
OxyContin
Opioid Analgesic
oxycodone hydrochloride
15mg, 30mg and 60mg 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
10mg, 15mg, 20mg, 30mg, 40mg, 60mg and 80mg 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
0.7mg 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
0.7mg 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
0.7mg 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
Pdp- Levetiracetam
As adjunctive therapy in the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy.
levetiracetam
100 mg/mL oral solution
07/07/2022 Active
Pegasys/Pegasys RBV
Treatment of adult patients with chronic Hepatitis C
peginterferon alfa-2a /peginterferon alfa-2a & ribavirin
180mcg/0.5mL solution;
180mcg/0.5mL/250mg solution/tablet kit;
180mcg/0.5mL/200mg 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
420mg/14mL 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
420mg/14mL / 440mg/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
150mg, 200mg, 50mg + 200mg 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
80mg/mL / 40mg/mL and
60mg/mL / 60mg/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
63mcg, 94mcg & 125mcg
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
20mg 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
1mg, 2mg, 3mg and 4mg 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
1mg, 2mg, 3mg and 4mg capsule
24/09/2019 Active
Ponstan
For the relief of acute pain of moderate severity in various conditions
mefenamic acid
250mg capsule
15/06/2018 File Closed
Posanol
Treatment of invasive aspergillosis
posaconazole
40mg/mL oral suspension
23/04/2013 Reconsideration Completed
Posanol
Prophylaxis of Aspergillus and Candida infections and treatment of invasive aspergillosis
posaconazole
100mg DR tablet
05/05/2015 First Review Completed
Pradaxa
Venous thromboembolism prevention
dabigatran etexilate mesilate
75mg and 110mg capsule
02/05/2013 Second Review Completed
Pradaxa
Prevention of stroke and systemic embolism in patients with atrial fibrillation
dabigatran etexilate mesilate
110mg and 150mg 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
800mg/150mg tablet
06/07/2016 First Review Completed
Prezista
HIV in pediatric patients
darunavir ethanolate
75mg tablet
27/11/2015 First Review Completed
Prezista
HIV in pediatric patients
darunavir ethanolate
150mg tablet
27/11/2015 First Review Completed
Prezista
HIV in previously untreated adult patients
darunavir ethanolate
400mg tablet
27/11/2015 First Review Completed
Prezista
HIV infection in previously untreated adult patients
darunavir ethanolate
600mg 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
800mg tablet
27/11/2015 First Review Completed
Pristiq
Major depressive disorder
desvenlafaxine succinate
50mg and 100mg 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
80mg 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)
1000mg/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
60mg/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
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
240mg/2.4mL 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 ORS
For the treatment of amyotrophic lateral sclerosis

EDARAVONE
105 mg/5 mL oral suspension

29/08/2022 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
4mg and 8mg 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
150mg/12.5mg,
150mg/25mg,
300mg/12.5mg and
300mg/25mg 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
66mcg/1.5mL and 132mcg/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
44mcg/0.5mL and 132mcg/1.5mL (44mcg 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
25mg/vial and 75 mg/vial, subcutenous 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
100mg/mL, 150mg/mL PFS, Vial
30/04/2021 First Review Completed
Relaxa
For the treatment of occasional constipation in adults
polyethylene glycol 3350
510g powder for suspension
17/08/2012 Withdrawn
Relenza
Influenza A and B infection
zanamivir
5mg/blister powder for inhalation
01/03/2010 First Review Completed
Relistor
Constipation, Opioid-Induced
methylnaltrexone bromide
20mg/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
800mg 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
1mg and 2mg 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
5mg, 10mg, 15mg and 25mg capsule
21/08/2009 First Review Completed
Revlimid
As maintenance treatment of newly diagnosed multiple myeloma patients after stem-cell transplantation
lenalidomide
5mg, 10mg, 15mg and 25mg 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
5mg, 10mg, 15mg and 25mg 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
20mg 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
25mg and 50mg 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
25mg and 50mg 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
10mg/mL injection
29/01/2015 Reconsideration Completed
Rituxan
Previously untreated chronic lymphocytic leukemia
rituximab
10mg/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
For the treatment of chronic lymphocytic leukemia (CLL)
rituximab
120 mg/mL solution for subcutaneous injection (1600mg/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
10mg/ mL Inj Sol
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
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
Saizen
Growth hormone deficiency
somatropin
6mg/cartridge (5.83mg/mL), 12mg/cartridge (8mg/mL) and 20mg/cartridge (8mg/mL)
18/01/2012 First Review Completed
Samsca
For the treatment of clinically important, non-hypovolemic hyponatremia
tolvaptan
15mg, 30mg and 60mg tablet
28/01/2014 Second Review Completed
Sanctura XR
Overactive bladder
trospium chloride
60mg 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
5mg and 10mg 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
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
50mcg 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
150mg ER tablet
07/01/2011 First Review Completed
Signifor
For the treatment of patients with Cushing’s disease
pasireotide diaspartate
0.3mg/ mL, 0.6mg/ mL and 0.9mg/ 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
210mg/1.5mL, sub-cutaneous injection, pre-filled syringe
23/04/2019 First Review Completed
Silkis
Antipsoriatic agent
calcitriol
3mcg/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
50mg/ 0.5mL solution
07/12/2010 First Review Completed
Simponi
Psoriatic arthritis
golimumab
50mg/ 0.5mL solution
07/01/2011 First Review Completed
Simponi
Ankylosing spondylitis
golimumab
50mg/0.5mL 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
50mg/ 0.5mL and 100mg/ 1.0mL 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
50mg/4mL solution for infusion
30/11/2015 First Review Completed
Skyrizi
For the treatment of moderate to severe plaque psoriasis.
RISANKIZUMAB
75mg in 0.83mL (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
10mg/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
10mg/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
400mg tablet
25/02/2015 First Review Completed
Spinraza
For the treatment of Type 1 spinal muscular atrophy (SMA) according to clinical criteria.
nusinersen sodium
2.4mg/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
2.4mg/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
2.5mcg 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
100mg tablet
27/03/2012 First Review Completed
Stalevo
Parkinson’s Disease
carbidopa/ levodopa/ entacapone
75mg and 125mg tablet
03/11/2010 First Review Completed
Stalevo
Parkinson’s Disease
carbidopa/ levodopa/ entacapone
50mg, 100mg and 150mg 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
45mg/ 0.5mL solution
20/09/2010 First Review Completed
Stelara
Psoriasis
ustekinumab
90mg/ 1mL pre-filled syringe
28/11/2013 First Review Completed
Stelara
For the treatment of moderate to severe Psoriatic Arthritis
ustekinumab
45mg/0.5mL and
90mg/1mL 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
90mg/ 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
40mg 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
40mg 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
40mg tablet
30/11/2015 First Review Completed
Stivarga
Treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib
regorafenib
40mg 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

150mg/ 150mg/
200mg/ 300mg 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
5mg and 10mg 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
100mg 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
100mg/ vial, 400mg/ 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
800mg/ 150mg/ 200mg/ 10mg
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
50mg and 75mg 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
50mg and 75mg 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
50mg, 75mg capsule &
0.5mg, 2mg 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
50mg, 75mg capsule &
0.5mg, 2mg 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
50mg, 75mg capsule &
0.5mg, 2mg 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 mesylate
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 mesylate
40 mg and 80 mg tablet
10/01/2020 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
44229 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
80mg/mL solution (subcutaneous) pre-filled auto-injector and 80mg/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
30mg and 45mg capsule
21/03/2011 First Review Completed
Tamiflu
Antiviral agent
oseltamivir phosphate
6mg/mL powder for suspension
25/09/2012 File Closed
Tapazole
For the treatment of hyperthyroidism
methimazole
5mg 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 pre-filled syringe and 110 mg/mL pre-filled pen

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
25mg, 100mg and
150mg tablet
20/10/2011 First Review Completed
Targin
Relief of pain and opioid induced constipation
oxycodone hydrochloride/naloxone hydrochloride
10/ 5mg, 20/ 10mg and
40/ 20mg 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
200mg 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
150mg 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
20mg/ 0.5mL and
80mg/ 2.0mL 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
1200mg/ 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
1200mg/ 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
1200mg/ 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
840mg /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
1200mg/ 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
120mg 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
240mg 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

12.5mg/ 75mg/ 50mg tablet
31/03/2016 Active
Tecta
Conditions where a reduction of gastric acid secretion is required
pantoprazole magnesium
40mg 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
Temodal
Newly diagnosed glioblastoma multiforme. Recurrent or progressive glioblastoma multiforme or anaplastic astrocytoma
temozolomide
140mg 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
50mg capsule
19/10/2012 First Review Completed
Tivicay
For the treatment of human immunodeficiency virus (HIV)
dolutegravir sodium
50mg 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
28mg 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
28mg 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
10mg and 30mg 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
4mg and 8mg 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
5mg 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 (MBC)
The treatment of patients with metastatic breast cancer (MBC) whose tumours overexpress HER2. Trazimera (trastuzumab) 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
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
25mg/8mL and 100mg/20mL
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
62.5mg & 25mg, dry powder inhaler
20/09/2019 First Review Completed
Trelstar
The palliative treatment of hormone dependent advanced carcinoma of the prostate gland
triptorelin pamoate
22.5mg 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
100mg/mL solution,
prefilled syringe
06/03/2018 Active
Tremfya
For the treatment of adult patients with active psoriatic arthritis. TREMFYA/TREMFYA One-Press can be used alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate)
GUSELKUMAB
100 mg/mL prefilled syringe (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
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
5mg, 10mg and 20mg tablet
04/08/2015 File Closed
Trintellix
For the treatment of major depressive disorder (MDD) in adults
vortioxetine hydrobromide
5mg, 10mg and 20mg 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

50mg/ 600mg/ 300mg 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
0.75mg/0.5mL,
1.5mg/0.5mL single use pen,
subcutaneous solution for injecton
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
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
Tudorza Genuair
Long-term maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
aclidinium bromide
400mcg/ 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
40mg/5mg, 40mg/10mg,
80mg/5mg and
80mg/10mg 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
40mg/5mg, 40mg/10mg,
80mg/5mg and
80mg/10mg tablet
12/08/2011 Withdrawn
Tykerb
Advanced or metastatic breast cancer which overexpress Her2
lapatinib ditosylate
250mg 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
250mg tablet
27/11/2013 First Review Completed
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

28/09/2022 Active
Uloric
To lower serum uric acid levels in patients with gout
febuxostat
80mg 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
3.5mg/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
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 solution (IV infusion)

15/09/2022 Active
Vagifem LD
Vaginal atrophy due to estrogen deficiency
estradiol hemihydrate
10mcg 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
100mg/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
100mg/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
3.5mg powder for injection
13/05/2009 First Review Completed
Velcade
First – line treatment of multiple myeloma
bortezomib
3.5mg 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
3.5mg 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
10mcg, 50mcg,
100mcg FC Tablet,
10mcg/ 50mg/ 100mcg
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
10mcg, 50mcg,
100mcg FC Tablet,
10mcg/ 50mg/ 100mcg
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
75mg and 100mg tablets
25/07/2018 Active
Victoza
Treatment of adults with Type 2 diabetes
liraglutide
6mg/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
200mg capsule
04/01/2012 First Review Completed
Vidaza, Pre-Notice of Compliance
Myelodysplastic syndrome
azacitidine
100mg/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
1mg/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
50mg, 100mg, 150mg and
200mg FC tablet
01/05/2012 First Review Completed
Viramune XR
Treatment of HIV-1 infection in combination with other antiretroviral agents
nevirapine
400mg ER tablet
19/07/2012 First Review Completed
Viread
Chronic hepatitis B in adults
tenofovir disoproxil fumarate
300mg tablet
16/06/2009 First Review Completed
Visanne
For the management of pelvic pain associated with endometriosis
dienogest
2mg 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
30mg tablet
30/11/2021 First Review Completed
Volibris
Pulmonary arterial hypertension
ambrisentan
5mg and 10mg 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
200mg 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
200mg 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
30mg and 50mg capsule
16/06/2011 First Review Completed
Vyvanse
Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years
lisdexamfetamine dimesylate
20mg, 40mg and 60mg capsule
16/06/2011 First Review Completed
Vyvanse
Attention Deficit Hyperactivity Disorder (ADHD)
lisdexamfetamine dimesylate
10mg 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
200mg and 250mg 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
200mg and 250mg capsule
05/01/2016 First Review Completed
Xamiol
Psoriasis
calcipotriol/ betamethasone
50mcg/g and
0.5mg/g topical gel
19/05/2011 First Review Completed
Xarelto
Prevention of venous thromboembolic events (VTE)
rivaroxaban
10mg 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
15mg and 20mg FC tablet
25/07/2012 First Review Completed
Xarelto
For the treatment of deep vein thrombosis (DVT) in patients without symptomatic pulmonary embolism
rivaroxaban
15mg and 20mg FC tablet
11/12/2012 First Review Completed
Xarelto
For the treatment of pulmonary embolism (PE)
rivaroxaban
15mg and 20mg 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
10mg 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
5mg 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
11mg, 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
150mg and 500mg 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
120mg/ 1.7mL 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
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
40mg 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
40mg 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
500mg/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
Yervoy
For the treatment of unresectable or metastatic melanoma
ipilimumab
5mg/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
5mg/ 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
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
1mg/ 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
25mg/ mL IV solution
30/11/2015 File Closed
Zaxine
Reduction in risk of overt hepatic encephalopathy recurrence in patients ≥18 years of age
rifaximin
550mg 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
240mg 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 infection in adults
elbasvir & grazoprevir
50mg & 100mg tablet
26/06/2018 First Review Completed

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