Drug Submissions
Status For Single-Source Submissions
| Brand Name and Indication |
Generic Name and Strength |
Date Published (DD/MM/YYYY) |
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 |
| Abraxane Metastatic pancreatic cancer |
nab-paclitaxel 100mg/vial |
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 |
21/03/2022 | Active |
| 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glucose dehydrogenase | 04/01/2012 | Withdrawn |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 |
09/04/2021 | Active |
| 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 |
08/03/2022 | Active |
| Aybintio Antineoplastic |
BEVACIZUMAB 25 mg/mL (100mg/4 mL) and 25 mg/mL (400mg/16mL) single use vial |
25/02/2022 | 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 As a monotherapy for the first line treatment of adult patients with anaplastic lymphoma kinase (ALK) – positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). |
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 topical treatment of acne vulgaris in patients 10 years of age and older. |
TAZAROTENE 0.045% lotion |
19/11/2021 | Active |
| 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 |
| 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 |
25/03/2022 | Active |
| 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 |
| 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 |
30/03/2021 | Active |
| 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 |
01/12/2020 | Active |
| 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 |
29/05/2018 | Active |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
29/02/2016 | 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 | Active |
| 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 (SMA) in patients 2 months of age and older. |
risdiplam 0.75 mg/mL powder for solution |
04/05/2021 | Active |
| 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 |
| 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 |
| 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 |
18/09/2018 | Active |
| 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 |
| 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 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 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 Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult Crohn’s Disease, Ulcerative Colitis, Hidradenitis Suppurativa, Plaque Psoriasis, Adult Uveitis. |
adalimumab 40mg/ 0.8mL and 20mg/0.4mL SC solution (autoinjector pen and prefilled syringe) |
29/03/2021 | 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 |
04/05/2021 | Active |
| 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 |
15/03/2021 | Active |
| 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 |
| 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 |
| 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 |
30/10/2020 | Active |
| 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 420 mg/vial IV Powder for Solution, Kit |
04/04/2021 | 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 adult patients with relapsing forms of multiple sclerosis (RMS). |
ofatumumab 20 mg / 0.4 mL SC solution for injecton |
04/05/2021 | 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 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 powder for solution for infusion 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 powder for solution for infusion 50 mg solution for infusion 100 mg/4mL vial |
23/10/2019 | Active |
| Keytruda For the adjuvant treatment of melanoma (ADJ MEL). |
pembrolizumab powder for solution for infusion 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 powder for solution for infusion 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. |
prembrolizumab 100mg/4mL solution for infusion vial |
15/02/2022 | 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 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 |
| 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 |
| 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 As monotherapy 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 |
| 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 |
| Mayzent For the treatment of patient with secondary progressive multiple sclerosis. |
siponimod 0.25 mg and 2 mg tablet |
13/02/2020 | Active |
| 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 |
| 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 |
| 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 |
| 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 other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (also known as progressive fibrosing ILD) (PF-ILD) |
nintedanib esilate 100 mg and 150 mg capsules |
26/11/2020 | Active |
| 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 |
| 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 |
| 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 |
| 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 & 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 |
09/12/2020 | Active |
| 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 |
| 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 |
17/08/2020 | 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 |
22/10/2020 | 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 |
| 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 |
| Radicava For the treatment of amyotrophic lateral sclerosis (ALS). |
edaravone 30 mg / 100 mL solution |
14/02/2019 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
03/03/2022 | Active |
| 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 |
| 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 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 |
| Ultomiris For the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). |
RAVULIZUMAB 10 mg/mL IV solution |
23/12/2021 | 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 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 |
02/06/2021 | Active |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
31/03/2021 | Active |
| 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 |
| Vyndaqel For the treatment of adult patients with cardiomyopathy due to transthyretin (TTR) -mediated amyloidosis according to clinical criteria. |
tafamidis meglumine 20 mg capsule |
12/05/2021 | 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 |
15/03/2022 | 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) |
02/03/2022 | 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 |
| 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 |
| 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 |
| Zeposia For the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations. |
ozanimod HCl 0.92 mg gelatin capsule, 0.23 mg/ 0.46 mg gelatin capsule (kit) |
06/11/2020 | Active |
| Wakix For the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. |
PITOLISANT HCl 5 mg and 20 mg tablet |
10/03/2022 | Active |
| Zeulide Depot For the palliative treatment of advanced and/or metastatic prostate cancer. |
leuprolide acetate 3.75 mg [1-Month] and 22.5 mg [3-Month], Intramuscular Injection. |
04/11/2019 | Active |
| Ziextenxo To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. |
pegfilgrastim 6 mg (10 mg/ml), sterile solution for injection |
28/08/2020 | First Review Completed |
| Zinbryta For the treatment of adult patients with active relapsing remitting multiple sclerosis (RRMS) who have had an inadequate response to, or who are unable to tolerate, one or more therapies indicated for the treatment of multiple sclerosis (MS). |
daclizumab beta 150mg/mL solution for injection |
08/08/2017 | Active |
| Zirabev For the treatment of various cancers, according to clinical criteria. |
bevacizumab 100 mg (25 mg/mL solution for injection) and 400 mg (25 mg/mL solution for injection) intravenous solution. |
31/10/2019 | First Review Completed |
| Zolgensma For the treatment of spinal muscular atrophy (SMA) in patients who meet clinical criteria. |
onasemnogene abeparvovec 2 x 1013 vector genomes/mL, solution for intravenous infusion |
29/10/2021 | First Review Completed |
| Zometa Bone metastases due to renal cell carcinoma (mRCC) |
zoledronic acid 4mg/5mL solution |
04/10/2010 | First Review Completed |
| Zometa Adjuvant treatment of hormone receptor-positive early breast cancer in pre-menopausal women |
zoledronic acid 4mg/5mL solution |
04/10/2010 | First Review Completed |
| Zometa For the treatment of patients with osteolytic lesions of multiple myeloma |
zoledronic acid 4mg/5mL solution |
31/07/2013 | First Review Completed |
| Zyclara Treatment of actinic keratoses |
imiquimod 3.75% topical cream |
05/12/2012 | Withdrawn |
| Zydelig In combination with rituximab for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL) |
idelalisib 100mg and 150mg tablet |
28/03/2017 | First Review Completed |
| Zydelig As a monotherapy for the treatment of patients with follicular lymphoma (FL) who have received at least two prior systemic regimens and are refractory to both rituximab and an alkylating agent |
idelalisib 100mg and 150mg tablet |
03/11/2016 | File Closed |
| Zykadia As monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib |
ceritinib 150mg capsules |
04/03/2016 | First Review Completed |
| Zykadia As monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib |
ceritinib 150mg capsules |
22/11/2018 | First Review Completed |
| Zytiga In combination with prednisone for the treatment of metastatic prostate cancer (castration-resistant prostate cancer) in patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy |
abiraterone acetate 250mg tablet |
30/11/2015 | First Review Completed |
| Zytiga For the treatment of metastatic castrate-resistant prostate cancer (mCRPC) |
abiraterone acetate 500mg FC tablet |
06/06/2017 | First Review Completed |
| Zytiga, Pre-Notice of Compliance For the treatment of metastatic prostate cancer in patients who have received prior chemotherapy |
abiraterone acetate 250mg tablet |
04/01/2012 | First Review Completed |
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