Drug Submissions

Status For Single-Source Submissions

Brand Name and Indication	Generic Name and Strength	Date Published	Status
Abilify Schizophrenia and related psychotic disorders	aripiprazole 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablet	19/10/2011	First Review Completed
Abilify For major depressive disorder	aripiprazole 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablet	27/10/2015	First Review Completed
Abilify Maintena For the maintenance treatment of schizophrenia in stabilized adult patients	aripiprazole 300 mg/vial and 400 mg/vial powder for suspension, SR (IM)	04/08/2015	First Review Completed
Aptivus For the treatment of HIV/AIDS according to clinical criteria.	tirpranavir 250 mg capsule	29/04/2022	First Review Completed
Abraxane Metastatic breast cancer	paclitaxel 100 mg/vial powder for injection	30/06/2011	Reconsideration Completed
Abraxane Metastatic pancreatic cancer	nab-paclitaxel 100 mg/vial powder for injection	05/05/2015	First Review Completed
Abevmy Antineoplastic	BEVACIZUMAB 25 mg/mL (400 mg/16 mL) and 25 mg/mL (100 mg/4 mL) IV solution, single use vial	29/04/2022	First Review Completed
ATECTURA BREEZHALER Indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older with reversible obstructive airways disease	Indacaterol (as acetate)/ mometasone furoate 150 mcg/80 mcg, 150 mcg/160 mcg, 150 mcg/320 mcg inhalation powder hard capsules use vial	28/02/2022	First Review Completed
Abraxane for Injectable Suspension Metastatic breast cancer	paclitaxel 100 mg/vial	30/06/2011	Reconsideration Completed
Abstral For breakthrough pain in patients with cancer, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain	fentanyl citrate 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg sublingual tablet	03/04/2012	First Review Completed
Accel-Sevelamer For the treatment of hyperphosphatemia according to clinical criteria.	sevelamer carbonate 800 mg FC tablet	17/04/2020	First Review Completed
Accu-Chek Guide Test Strips To measure the concentration of glucose in the blood	FAD glucose dehydrogenase (GDH)	08/08/2017	First Review Completed
Accu-Chek Inform ll Glucose Test Strips To measure the concentration of glucose in the blood	quinoprotein glucose dehydrogenase	25/03/2014	First Review Completed
Accu-Chek Mobile To measure the concentration of glucose in the blood	glucose oxi-reductase	27/10/2015	Reconsideration Completed
Accu-Chek Performa Test Strips To measure the concentration of glucose in the blood	glucose dehydrogenase	04/01/2012	Withdrawn
Actemra Moderate to severe rheumatoid arthritis	tocilizumab 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL intravenous solution	23/01/2014	Reconsideration Completed
Actemra Polyarticular Juvenile Idiopathic Arthritis (pJIA)	tocilizumab 20 mg/mL concentrate solution for infusion	17/06/2015	First Review Completed
Actemra Reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who have inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF) antagonists	tocilizumab 162 mg/0.9 mL subcutaneous solution	27/10/2015	First Review Completed
Actemra For the treatment of giant cell arteritis (GCA) in adult patients	tocilizumab 162 mg/0.9 mL subcutaneous solution	17/04/2019	First Review Completed
Actemra For the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and giant cell arteritis according to clinical criteria.	tocilizumab 162 mg / 0.9 mL subcutaneous solution, single-use prefilled autoinjector	31/03/2020	First Review Completed
Actemra For the treatment of patients with Polyarticular Juvenile Idiopathic Arthritis (pJIA).	tocilizumab 162 mg/ 0.9 mL SC solution, single-use prefilled syringe	26/02/2020	First Review Completed
Actemra SC For use of subcutaneous (SC) administration of Actemra for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with one or more non-steroidal anti-inflammatory drugs and systemic corticosteroids.	tocilizumab 162 mg/ 0.9 mL SC solution, pre-filled syringe (PFS) and autoinjector device (AI) (the addition of a new route of administration).	44140	First Review Completed
Actikerall For the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (Grade I/II) of the face, forehead, and balding scalp in immunocompetent adult patients	fluorouracil & salicyclic acid 0.5 %/10 % w/w solution	24/10/2018	First Review Completed
Actonel Osteoporosis	risedronate sodium 150 mg tablet	16/06/2009	First Review Completed
Actonel DR Treatment and prevention of osteoporosis	risedronate sodium 35 mg DR tablet	17/02/2012	First Review Completed
Acuvail For the treatment of pain and inflammation following cataract surgery	ketorolac tromethamine 0.45 % w/v ophthalmic solution	23/04/2013	First Review Completed
Adalat XL Plus For use in patients for whom treatment of both nifedipine and acetylsalicylic acid is appropriate	nifedipine/acetylsalicylic acid 20 mg/81 mg, 30 mg/81 mg and 60 mg/81 mg ER tablet	26/03/2009	File Closed
Adcetris The treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates	brentuximab vedotin 50 mg lyophilized powder	20/02/2014	First Review Completed
Adcetris For the post-Autologous Stem Cell Transplant (ASCT) consolidation treatment of patients with Hodgkin Lymphoma (HL) at increased risk of relapse or progression	brentuximab vedotin 50 mg lyophilized powder	17/12/2019	First Review Completed
Adcetris For patients after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates.	brentuximab vedotin 50 mg lyophilized powder	20/02/2019	File Closed
Adcetris For the post-Autologous Stem Cell Transplant (ASCT) consolidation treatment of patients with Hodgkin Lymphoma (HL) at increased risk of relapse or progression	brentuximab vedotin 50 mg lyophilized powder	17/12/2019	First Review Completed
Adcetris For patients after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates.	brentuximab vedotin 50 mg lyophilized powder	20/02/2019	File Closed
Adcetris For the treatment of previously untreated peripheral T-cell lymphoma (PTCL) according to clinical criteria.	brentuximab vedotin 50 mg/vial powder for solution	10/11/2020	First Review Completed
Adcetris For the treatment of adult patients with CD30-positive primary cutaneous anaplastic large cell lymphoma (pcALCL) or mycosis fungoides (MF) according to clinical criteria	brentuximab vedotin 50 mg/vial powder for solution	09/12/2021	First Review Completed
Adcetris In combination with AVD, be reimbursed for the treatment of previously untreated patients with Stage IV HL	brentuximab vedotin 50 mg lyophilized powder for injection	04/11/2021	First Review Completed
Adcirca Pulmonary arterial hypertension	tadalafil 20 mg tablet	21/03/2011	First Review Completed
Adempas For the management of inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4) and persistent or recurrent CTEPH after surgical treatment in adult patients (â‰¥18 years of age) with WHO Functional Class II or III pulmonary hypertension	riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg FC tablet	27/10/2015	First Review Completed
Adempas As monotherapy or in combination with endothelin receptor antagonists (ERAs) in adult patients (â‰¥18 years of age) with WHO Functional Class II or III pulmonary hypertension	riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg, and 2.5 mg tablet	26/06/2018	First Review Completed
Adlyxine For once-daily in combination with a basal insulin alone, or in combination with metformin, for the treatment of adults with Type 2 diabetes who are uncontrolled on basal insulin therapy	lixisenatide 0.05 mg/mL (10 mcg/dose), 0.1 mg/mL (20 mcg/dose) single-use pre-filled pen, 0.05 mg/mL & 0.1 mg/mL (10 mcg/dose & 20 mcg/dose) starter kit SC solution	20/12/2019	First Review Completed
Admelog Anti-Diabetic Agent	insulin lispro 100 units/mL solution for injection	18/12/2020	First Review Completed
Advagraf Prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants	tacrolimus 3 mg capsule	21/03/2011	First Review Completed
Aermony RESPICLICK The maintenance treatment of steroid-responsive bronchial asthma as prophylactic therapy in patients 12 years of age and older	fluticasone propionate 55 mcg, 113 mcg and 232 mcg dry powder for inhalation	29/03/2021	First Review Completed
Afinitor Treatment of metastatic renal cell carcinoma (mRCC)	everolimus 10 mg tablet	21/03/2011	First Review Completed
Afinitor For the treatment of adult patients (â‰¥ 18 years of age) with renal angiomyolipoma associated with tuberous sclerosis complex (TSC), who do not require immediate surgery	everolimus 2.5 mg, 5 mg and 10 mg tablet	27/10/2015	First Review Completed
Afinitor The treatment of Subependymal Giant Cell Astrocytoma (SEGA) associated with Tuberous Sclerosis Complex	everolimus 2.5 mg, 5 mg and 10 mg tablet	18/06/2018	First Review Completed
Afinitor For the treatment of unresectable, locally advanced or metastatic well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal or lung origin in adults with progressive disease	everolimus 2.5 mg, 5 mg and 10 mg tablet	23/11/2017	First Review Completed
Afinitor Treatment of neuroendocrine tumours of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease	everolimus 2.5 mg, 5 mg and 10 mg tablet	31/07/2013	First Review Completed
Afinitor Treatment of post menopausal women in combination with exemestane after progression or recurrence (failure) with non-steroidal aromatase inhibitor therapy	everolimus 2.5 mg, 5 mg and 10 mg tablets	27/10/2015	First Review Completed
Aimovig Prevention of migraine in adults who have at least 8 migraine days per month and who have previously failed, are intolerant, or have a contraindication to at least two migraine preventive therapies	erenumab 70 mg/mL and 140 mg/mL pre-filled autoinjector	24/09/2019	File Closed
Ajovy For the prevention of migraine in adults who have at least 4 migraine days per month	fremanezumab 150 mg/mL, subcutaneous solution	03/03/2022	First Review Completed
Ajovy For the prevention of migraine in adults who have at least 4 migraine days per month	fremanezumab 225 mg/1.5 mL (150mg/mL) SC solution, single dose prefilled autoinjector	09/06/2022	First Review Completed
Aybintio Antineoplastic	BEVACIZUMAB 25 mg/mL (100mg/4 mL) and 25 mg/mL (400mg/16mL) single use vial	15/07/2022	First Review Completed
Albrioza For the treatment of people living with amyotrophic lateral sclerosis (ALS) who have been diagnosed by a specialist experienced in the diagnosis and management of ALS and who are not currently requiring permanent non-invasive or invasive ventilation	sodium phenylbutyrate and ursodoxicoltaurine 3 g/ 1 g oral sachet, powder for suspension	21/06/2022	Active
Bijuva Treatment of moderate to severe vasomotor symptoms associated with menopause in women with intact uterus	ESTRADIOL, PROGESTERONE 0.5 mg, 100 mg and 1 mg, 100 mg capsule	08/03/2022	Active
Akynzeo For the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy. For the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone	netupitan & palonosetron 300 mg & 0.5 mg capsule	28/06/2019	First Review Completed
Alecensaro As monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancers (NSCLC) who have progressed on or are intolerant to crizotinib and have CNS metastases	alectinib HCl 150 mg capsule	17/04/2019	First Review Completed
Alecensaro A monotherapy for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC)	alectinib HCl 150 mg capsule	15/08/2018	Active
Alimta Second-line treatment of non-small cell lung cancer	pemetrexed 100 mg/vial	01/03/2010	First Review Completed
Alimta First-line treatment of non-small cell lung cancer	pemetrexed 500 mg/vial	10/07/2009	First Review Completed
Alimta Maintenance treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer	pemetrexed 100 mg/vial and 500 mg/vial	04/01/2012	Second Review Completed
Alimta As monotherapy for the maintenance treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer	pemetrexed 100 mg/500 mg vial IV powder for solution	27/10/2015	First Review Completed
Allevia Plus Blood Glucose Strips To measure the concentration of glucose in the blood	FAD-glucose dehydrogenase	28/03/2017	Active
Aloxi Prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy	palonosetron 0.5 mg capsule	29/08/2013	First Review Completed
Aloxi Prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy	palonosetron 0.5 mg capsule	31/07/2015	File Closed
Alunbrig As a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic nonÃ¢â‚¬“small cell lung cancer (NSCLC) who have progressed on or who were intolerant to an ALK inhibitor (crizotinib)	brigatinib 30 mg, 90 mg, 180 mg tablet, and 90 mg/ 180 mg starter pack, tablet.	10/02/2022	First Review Completed
Alunbrig For the treatment of anaplastic lymphoma kinaseÃ¢â‚¬“positive locally advanced or metastatic non-small cell lung cancer according to clinical criteria	brigatinib 30 mg, 90 mg, 180 mg tablet, and 90 mg/ 180 mg starter pack, tablet.	10/02/2022	First Review Completed
Arazlo For the treatment of acne vulgaris	TAZAROTENE 0.045 % lotion	31/10/2022	First Review Completed
Amgevita Polyarticular Juvenile Idiopathic Arthritis, Hidradenitis Suppurativa, Uveitis, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult Crohn’s Disease, Pediatric Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Pediatric Uveitis	ADALIMUMAB 50 mg/mL solution for SC injection, prefilled syringe and autoinjector	29/03/2021	First Review Completed
Amgevita For inducing and maintaining clinical remission in pediatric patients 5 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine (6-MP) or who are intolerant to such therapies	ADALIMUMAB 50 mg/mL solution for SC injection, prefilled syringe and autoinjector	07/11/2022	Active
Androderm Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism)	testosterone 24.3 mg transdermal patch	20/02/2014	First Review Completed
Anoro Ellipta For the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema	umeclidinium bromide/ vilanterol trifenatate 62.5mcg/ 25mcg/ powder for oral inhalation	29/06/2015	First Review Completed
Apidra Diabetes, Type 1 & 2	insulin glulisine 100 U/mL injection solution – 10 mL vial and 3 mL pack	21/08/2009	First Review Completed
Apidra Diabetes, Type 1 & 2	insulin glulisine 100 U/mL solution – 3 mL cartridge (ClickStar pen)	01/06/2010	First Review Completed
Aptiom As adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy who are not satisfactory controlled with conventional therapy	eslicarbazepine acetate 200 mg/ 400 mg / 600 mg / 800 mg tablet	25/11/2015	First Review Completed
Arbesda For the treatment asthma in patients aged 12 years and older.	fluticasone propionate & salmeterol 55 mcg/ 14 mcg, 113 mcg/ 14 mcg, and 232/ 14 mcg, dry-powder inhaler	12/02/2020	Active
Arnuity Ellipta For the once-daily maintenance treatment of steroid-responsive bronchial asthma in patients aged 12 years and older	fluticasone furoate 100 mcg (per actuation) and 200 mcg (per actuation) powder (oral inhalation)	29/09/2016	First Review Completed
Axiron For testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism)	testosterone 2% topical solution metered-dose pump/30 mg (1.5 mL) per actuation	24/06/2015	First Review Completed
Arzerra In combination with chlorambucil, for the patients with chronic lympocytic leukemia (CLL) who have not received prior therapy and for whom fludarabine-based therapy is considered appropriate	ofatumumab 20 mg/mL IV solution	24/06/2015	First Review Completed
Asmanex Twisthaler For the prophylactic management of steroid-response bronchial asthma in patients 12 years of age and older	mometasone furoate dry powder inhaler 200 mcg and 400 mcg metered inhalation	02/01/2013	First Review Completed
Asmanex Twisthaler As a preventative agent for the prophylactic management of steroid-responsive bronchial asthma in patients 4 years of age and older	mometasone furoate dry powder inhaler 100 mcg/ metered inhalation	27/10/2015	Active
Atacand Hypertension	candesartan cilexetil 32 mg tablet	20/05/2009	First Review Completed
Atacand Plus Hypertension	candesartan cilexetil/hydrochlorothiazide 32 mg/12.5 mg and 32 mg/25 mg tablet	20/08/2010	First Review Completed
ATECTURA BREEZHALER Indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older with reversible obstructive airways disease.	Indacaterol (as acetate)/ mometasone furoate 150 mcg/ 80 mcg, 150 mcg/ 160 mcg, 150 mcg/ 320 mcg inhalation powder hard capsules	28/02/2022	First Review Completed
Adtralza For the treatment of adult patients with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable and who had an adequate trial or be ineligible for each of the following therapies: phototherapy (where available), methotrexate, and cyclosporine.	TRALOKINUMAB 150 mg/mL SC Solution	23/12/2021	Active
Abrilada Biological Response Modifier	ADALIMUMAB 50 mg mL SC solution for injection, prefilled pen and prefilled syringe	31/05/2022	First Review Completed
Aubagio As monotherapy for the treatment of patients with relapsing remitting multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability	teriflunomide 14 mg tablet	24/11/2014	First Review Completed
Avastin Metastatic breast cancer	bevacizumab 100 mg/4 mL vial and 400 mg/ 16 mL vial IV solution	05/07/2011	Reconsideration Completed
Avastin Advanced metastatic or recurrent non-squamous non-small cell lung cancer	bevacizumab 100 mg/4 mL vial and 400 mg/ 16 mL vial IV solution	30/06/2010	First Review Completed
Avastin For treatment of patients with recurrent glioblastoma multiforme (GBM)	bevacizumab 100 mg/ 4mL SD Vial (25 mg/ mL) and 400 mg/ 16 mL (25 mg/ mL) IV solution	28/01/2014	Reconsideration Completed
Avastin In combination with paclitaxel, topotecan or pegylated liposomal doxorubicin for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens	bevacizumab 25 mg/mL solution for injection	03/05/2016	First Review Completed
Avastin In combination with chemotherapy for the treatment of patients with persistent, recurrent or metastatic carcinoma of the cervix	bevacizumab 25 mg/mL IV solution	18/06/2018	First Review Completed
Avastin In combination with paclitaxel and carboplatin for front-line treatment of epithelial ovarian, fallopian tube or primary peritoneal cancer patients with high risk of relapse (stage III sub-optimally debulked or stage III unresectable, or stage IV patients)	bevacizumab with paclitaxel & carboplatin 25 mg/mL IV solution	18/06/2018	First Review Completed
Avonex Pen Treatment of relapsing forms of multiple sclerosis	interferon beta - 1a 30mcg/ 0.5mL subcutaneous prefilled autoinjector or pen	19/10/2011	First Review Completed
Avsola Rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis, plaque psoriasis.	infliximab 100 mg / vial powder for solution (IV)	18/12/2020	First Review Completed
Axiron For testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism)	testosterone 2 % topical solution metered-dose pump/30 mg (1.5 mL) per actuation	24/06/2015	First Review Completed
Azarga Elevated intraocular pressure therapy	brinzolamide/timolol maleate 1 %/0.5 % ophthalmic suspension	30/06/2010	First Review Completed
Bambevi For the treatment of various cancer conditions according to clinical criteria.	bevacizumab 100 mg/4 mL, 400 mg/16 mL injection solution	15/12/2021	First Review Completed
Breztri Aerosphere For the long-term maintenance treatment to reduce exacerbations of chronic obstructive pulmonary disease (COPD) and treat airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema who are not adequately treated by a combination of an ICS/LABA or a combination of a LAMA/LABA	BUDESONIDE/FORMOTEROL FUMARATE DIHYDRATE/GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE) 182 mcg/5.8 mcg/ 8.2 mcg per ACT, PRESSURIZED INHALATION SUSPENSION, Aerosol, Metered Dose	31/10/2022	First Review Completed
Banzel For adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 4 years and older and adults	rufinamide 100 mg, 200 mg and 400 mg tablet	25/07/2012	First Review Completed
Basaglar For once-daily subcutaneous administration in the treatment of patients over 17 years of age with type 1 or type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. The treatment of pediatric patients (>6 years old) with type 1 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.	insulin glargine (rDNA origin) 100 units /mL/ SC solution	31/08/2017	First Review Completed
Bimzelx For the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.	BIMEKIZUMAB 160 mg/mL SC, solution for injection, pre-filled syringe and autoinjector	17/03/2022	Active
Basaglar Kwikpen For once-daily subcutaneous administration in the treatment of patients over 17 years of age with type 1 or type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia	insulin glargine 80 units/ injection, solution for injection (100 IU/ mL)	21/03/2019	First Review Completed
Bavencio Treatment of metastatic Merkel Cell Carcinoma (mMCC) in previously treated adults	avelumab 20 mg/mL solution for intravenous infusion	18/04/2019	First Review Completed
Bavencio For the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed with platinum-based induction chemotherapy.	avelumab 20 mg/mL solution for infusion	12/05/2022	First Review Completed
Benlysta In addition to standard therapy for reducing disease activity in adult patients with active, autoantibody-positive, systemic lupus erythematosis (SLE)	BELIMUMAB 120 mg/ vial and 400 mg/ vial lyophilized powder for IV infusion	27/05/2013	Reconsideration Completed
Benlysta In addition to standard therapy for reducing disease activity in adult patients with active autoantibody positive systemic Lupus Erythematosus (SLE)	BELIMUMAB 200 mg in 1mL solution for SC injection	15/11/2019	Active
Benlysta For the treatment of active lupus nephritis in adult patients in addition to standard therapy	BELIMUMAB 120 mg/vial and 400 mg/vial lyophilized powder for IV infusion	01/12/2022	Active
Beovu For the treatment of neovascular (wet) age-related macular degeneration (AMD).	BROLUCIZUMAB 120 mg/mL solution for intravitreal injection	17/12/2021	First Review Completed
Beovu For the treatment of diabetic macular edema	BROLUCIZUMAB 6 mg / 0.05 mL solution for intravitreal injection	04/01/2023	Active
Baqsimi For the treatment of severe hypoglycemia (SH) reactions in patients with diabetes mellitus who are receiving insulin therapy and are at high risk for SH, when impaired consciousness precludes oral carbohydrate.	GLUCAGON 3 mg glucagon per device (3 mg/dose), nasal powder – intranasal	31/01/2022	First Review Completed
Besponsa Treatment of relapsed or refractory (R/R) B-Cell precursor acute lymphoblastic Leukemia (ALL)	inotuzumab ozogamicin 1 mg powder for solution for infusion	23/08/2019	First Review Completed
Betaseron Initiation Pack Clinically isolated syndrome (CIS) and clinically definite multiple sclerosis (CDMS)	interferon beta-1b 0.3 mg/vial powder for solution	24/08/2011	First Review Completed
Bryhali For the topical treatment of corticosteroid-responsive dermatoses and the topical treatment of plaque psoriasis.	HALOBETASOL PROPIONATE 0.01 % w/w topical lotion	21/03/2022	Active
BGStar Blood Glucose Test Strip To measure the concentration of glucose in the blood	glucose oxidase 2.7IU	06/09/2012	First Review Completed
Biktarvy As a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with no known substitution associated with resistance to the individual components of BIKTARVY.	bictegravir/ emtricitabine/ tenofovir alafenamide 50 mg/200 mg/ 25 mg tablet	02/11/2018	Active
Blincyto For the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B precursor acute lymphoblastic leukemia (ALL)	blinatumomab 38.5 Âµg 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 Âµg lyophilized powder for solution for infusion	08/08/2017	Active
Blincyto For the treatment of adult patients with relapsed or refractory Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL).	blinatumomab 38.5 mcg, single-use vials, lyophilized powder for solution for infusion	25/02/2020	First Review Completed
Blincyto Patients with Philadelphia chromosome-negative CD19 positive B-precursor acute lymphoblastic leukemia (ALL) in first or second hematologic complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.	blinatumomab 38.5 mcg/vial lyophilized powder for solution	28/08/2021	First Review Completed
Bosulif For the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior TKI therapy, and for whom subsequent treatment with imatinib, nilotinib and dasatinib is not clinically appropriate.	bosutinib 100 mg and 500 mg tablet	26/06/2018	First Review Completed
Botox Management of strabismus, blepharospasm, cervical dystonia and spasticity	clostridium botulinum toxin type A 200 units/vial	26/07/2011	Reconsideration Completed
Botox For the treatment of blepharospasm, strabismus, cervical dystonia, focal spasticity, dynamic equinus foot deformity	clostridium botulinum toxin type A 50 units/vial	26/07/2011	First Review Completed
Botox For the treatment of urinary incontinence due to neurogenic detrusor overactivity resulting from neurogenic bladder associated with multiple sclerosis or subcervical spinal cord injury in adults who had an inadequate response to or are intolerant of anticholinergic medications	clostridium botulinum toxin type A 50 units/vial, 100 units/vial and 200 units/vial	02/01/2013	First Review Completed
Botox For the prophylaxis of headaches in adults with chronic migraine	clostridium botulinum toxin type A 50 units/vial, 100 units/vial and 200 units/vial	22/01/2015	First Review Completed
Botox For the treatment of overactive bladder with symptoms of urinary incontinence, urgency, and frequency, in adult patients who have an inadequate response to or are intolerant of anticholinergic medication	onabotulinumtoxinA 50 units/vial, 100 units/vial and 200 units/vial	27/10/2015	First Review Completed
Botox Criteria Change Request: Prophylaxis of headaches in adults with chronic migraine	onabotulinumtoxinA 50 units/vial, 100 units/vial and 200 units/vial	05/07/2018	First Review Completed
Botox Treatment for prophylaxis of headaches in adults with chronic migraine (> 15 days per month with headaches lasting 4 hours a day or longer).	onabotulinumtoxinA 50 unit/vial, 100 unit/vial, and 200 unit/vial powder for injection	06/06/2019	Active
Mektovi and Braftovi BRAFTOVI and MEKTOVI in combination for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation	BINIMETINIB and ENCORAFENIB 15 mg tablet and 75 mg capsule	06/12/2022	First Review Completed
Braftovi In combination with cetuximab, for the treatment of patients with metastatic colorectal cancer with a BRAF V600E mutation, after prior therapy	ENCORAFENIB 75 mg capsule	06/12/2022	First Review Completed
Bravo Blood Glucose Test Strip To measure the concentration of glucose in the blood	glucose oxidase 2.7 units	26/06/2018	File Closed
Brenzys Rheumatoid arthritis and ankylosing spondylitis	etanercept 50 mg/mL solution (subcutaneous) pre-filled syringe and 50 mg/mL solution (subcutaneous) pre-filled auto-injector	09/08/2017	First Review Completed
Brenzys Expanded indications of plaque psoriasis in adults and children, psoriatic arthritis in adults and juvenile idiopathic arthritis.	etanercept 50 mg/mL, solution for injection (prefilled syringe and prefilled autoinjector)	29/03/2021	First Review Completed
Breo Ellipta Is indicated for the long-term once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)	fluticasone furoate/vilanterol trifenatate 100 mcg/25 mcg dry powder for oral inhalation	27/10/2015	First Review Completed
Breo Ellipta For the once-daily maintenance treatment of asthma in patients aged 18 years and older with reversible obstructive airways disease	fluticasone furoate/vilanterol trifenatate 100 mcg/25 mcg & 200 mcg/25 mcg, dry powder for oral inhalation	26/06/2018	First Review Completed
Brilinta Secondary prevention of atherothrombotic events in patients with a history of myocardial infarction (MI occurred at least one year ago) and a high risk of developing an atherothrombotic event	ticagrelor 60 mg tablet	28/03/2017	Active
Brilinta, Pre-Notice of Compliance Prevention of thrombotic events in patients with Acute Coronary Syndromes	ticagrelor 90 mg tablet	23/04/2013	Reconsideration Completed
Brineura For the treatment of Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) disease/ tripeptidyl peptidase 1 (TPP1) deficiency, in patients who meet clinical criteria.	cerliponase alfa 150 mg/5 mL (30 mg/mL) solution for Infusion for Intracerebroventricular Infusion	29/11/2019	First Review Completed
Brivlera As adjunctive therapy in the management of partial-onset seizures in adult patients with epilepsy who are not satisfactorily controlled with conventional therapy	brivaracetam 10 mg, 25 mg, 50 mg, 75 mg, 100 mg tablet	14/12/2018	First Review Completed
BuTrans Management of persistent pain of moderate intensity in adults requiring continuous opioid analgesia for an extended period of time	buprenorphine 5 mcg/hr, 10 mcg/hr and 20 mcg/hr transdermal patch	17/05/2012	Second Review Completed
Byetta In combination with metformin and/or a sulfonylurea to improve glycemic control in patients with type 2 diabetes mellitus	exenatide 250 Âµg/mL subcutaneous solution for injection	22/10/2012	First Review Completed
Bystolic For the treatment of mild to moderate essential hypertension	nebivolol 2.5 mg, 5 mg, 10 mg and 20 mg tablet	18/07/2014	Reconsideration Completed
Byooviz For the treatment of neovascular (wet) age-related macular degeneration (AMD). For the treatment of visual impairment due to diabetic macular edema (DME). For the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). For the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM). For the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to ocular conditions other than AMD or PM, including but not limited to angioid streaks, post-inflammatory retinochoroidopathy, central serous chorioretinopathy or idiopathic chorioretinopathy	RANIBIZUMAB 10 mg/mL solution (intravitreal injection)	28/11/2022	Active
Cablivi For the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange (PE) and immunosuppressive therapy	CAPLACIZUMAB 11 mg/vial powder for solution (IV or SC)	21/09/2022	Active
Cabenuva As a complete regimen for the treatment of Human Immunodeficiency Virus-Type 1 (HIV-1) infection in adult patients to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (virologic suppression is defined as HIV-1 ribonucleic acid [RNA] level [viral load] of less than 50 copies/mL); Response to treatment with Cabenuva, defined as ongoing virologic suppression (as defined above), should be assessed every 6 months; Treatment should be discontinued if there is evidence of, – Sustained loss of virologic suppression (as defined above); OR – Development of resistance to, adverse events leading to lack of tolerability of,and/or lack of adherence to either component of the drug regimen; The prescriber must be approved for the Facilitated Access to HIV/AIDS Drug Products mechanism	cabotegravir & rilpivirine 200 mg/mL & 300 mg/mL injection solution	30/11/2021	First Review Completed
Cabometyx For advanced hepatocellular carcinoma (HCC) in patients who have previously been treated	cabozatinib 20 mg, 40 mg and 60 mg tablet	29/12/2021	First Review Completed
Cabometyx For the treatment of adult patients with advanced renal cell carcinoma who have received prior therapy	cabozatinib 20 mg, 40 mg, 60 mg FC tablet	01/04/2019	Active
Calquence Monotherapy for patients with chronic lymphocytic leukemia (CLL) who have received at least one therapy.	acalabrutinib 100 mg capsule	03/12/2021	First Review Completed
Calquence In combination with obinutuzumab or as monotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia.	acalabrutinib 100 mg capsule	3/12/2021	First Review Completed
Caprelsa For the treatment of symptomatic or progressive medullary thyroid cancer in adult patients with unresectable locally advanced or metastatic disease	vandetanib 100 mg and 300 mg tablet	24/10/2018	First Review Completed
CareSens N Blood Glucose Test Strip To measure the concentration of glucose in the blood	glucose oxidase	04/08/2015	First Review Completed
Caripul For the long-term intravenous treatment of primary pulmonary hypertension and secondary pulmonary hypertension due to scleroderma spectrum of diseases in NYHA functional Class III and Class IV patients who did not respond adequately to conventional therapy	epoprostenol sodium 0.5 mg / 1.5 mg per vial	16/01/2014	First Review Completed
Cayston Management of cystic fibrosis (CF) patients with chronic pulmonary Pseudomonas aeruginosa infections	aztreonam 75 mg/vial powder for solution	21/09/2012	First Review Completed
Celsentri Treatment experienced patients infected with HIV	maraviroc 150 mg and 300 mg tablet	25/02/2009	First Review Completed
Celsentri For treatment naÃ¯ve HIV-infection	maraviroc 150 mg and 300 mg tablet	05/10/2011	First Review Completed
Cesamet Management of nausea and vomiting associated with cancer therapy	nabilone 0.25 mg capsule	10/07/2009	First Review Completed
Â Cibinqo For the treatment of patients 12 years and older with refractory moderate to severe atopic dermatitis (AD), including the relief of pruritus, who have had an inadequate response to other systemic drugs (e.g. steroid or biologic), or for whom these treatments are not advisable	ABROCITINIB 50 mg, 100 mg & 200 mg tablet	26/08/2022	Active
Cimzia Moderate to severe active rheumatoid arthritis (RA)	certolizumab pegol 200 mg/mL pre-filled syringe	01/10/2010	First Review Completed
Cimzia For reducing signs and symptoms in adult patients with active ankylosing spondylitis	certolizumab pegol 200 mg/mL pre-filled syringe	24/11/2015	First Review Completed
Cimzia To be used alone or in combination with methotrexate for reducing signs and symptoms and inhibiting the progression of structural damage as assessed by X-ray, in adult patients with moderately to severely active Psoriatic Arthritis who have failed one or more DMARDs	certolizumab pegol 200 mg/mL pre-filled syringe	30/11/2015	First Review Completed
Cimzia In combination with methotrexate (MTX) in adult patients with moderately to severely active rheumatoid arthritis (RA). Cimzia alone or in combination with methotrexate (MTX) is indicated in adult patients with moderately to severely active psoriatic arthritis (PsA) who have failed one or more disease-modifying anti-rheumatic drugs (DMARDs). Cimzia is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)	certolizumab pegol 200 mg/mL pre-filled pen	05/04/2018	First Review Completed
Cimzia The treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy.	certolizumab pegol 200 mg/mL SC single use pre-filled syringe and pre-filled autoinjector	26/08/2019	Active
Cinqair As add-on maintenance treatment of adult patients with severe eosinophilic asthma who are inadequately controlled with medium-to-high-dose inhaled corticosteroids and an additional asthma controller(s) (e.g., LABA) and have a blood eosinophil count of â‰¥400 cells/ÂµL at initiation of the treatment	reslizumab 100 mg/10 mL solution for infusion	08/03/2017	Active
Cipralex Meltz For the symptomatic relief of Major Depressive Disorder (MDD)	escitalopram 10 mg and 20 mg orally disintegrating tablet	16/01/2014	First Review Completed
Ciprodex Antibacterial - Corticosteroid	ciprofloxacin HCl & dexamethasone 0.3 % / 0.1% otic suspension	30/05/2012	First Review Completed
Clindoxyl ADV Gel Topical treatment of moderate acne vulgaris characterized by the presence of comedones, papules and pustules	clindamycin / benzoyl peroxide 1 % / 3 % topical gel	21/01/2015	First Review Completed
Clinoleic 20% For parenteral nutrition in adults when oral or enteral nutrition is not possible, insufficient, or contraindicated.	refined olive oil and refined soybean oil 16 %/4 % w/w lipid emulsion for IV nutrition	08/11/2019	Active
Combivent Respimat For treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD)	ipratropium/salbutamol FDC 20 mcg/100 mcg inhalation solution	04/08/2015	Reconsideration Completed
Complera For use alone as a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment – naÃ¯ve adults	emtricitabine/rilpivirine/tenofovir disoproxil fumarate 200 mg/25 mg/300 mg FC tablet	21/09/2012	First Review Completed
Constella Treatment of irritable bowel syndrome with constipation (IBS-C) in adults	linaclotide 290 mcg capsule	29/02/2016	First Review Completed
Contour Next Blood Glucose Test Strips To measure the concentration of glucose in the blood	FAD glucose dehydrogenase	19/09/2013	First Review Completed
Contrave Indication: indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: – 30 kg/m2 or greater (obese) or – 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., controlled hypertension, type 2 diabetes mellitus, or dyslipidemia).	naltrexone HCl & bupropion HCl 8 mg & 90 mg ER tablet	03/04/2020	Active
Calquence Monotherapy for patients with chronic lymphocytic leukemia (CLL) who have received at least one therapy.	acalabrutinib 100 mg capsule	03/12/2021	First Review Completed
Calquence In combination with obinutuzumab or as monotherapy for the treatment of patients with previously untreated chronic lymphocytic leukemia.	acalabrutinib 100 mg capsule	03/12/2021	First Review Completed
Copaxone Clinically Isolated Syndrome (CIS), after a first demyelinating event	glatiramer acetate 20 mg/1 mL pre-filled syringe	07/01/2011	First Review Completed
Copaxone Treatment of ambulatory patients with Relapsing Remitting Multiple Sclerosis (RRMS): 1) To decrease the frequency of clinical exacerbations and 2) To reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans	glatiramer acetate 40 mg/mL subcutaneous injection	29/05/2018	Active
Cortiment MMX For the induction of remission in patients with active, mild to moderate ulcerative colitis	budesonide 9 mg delayed and extended-release tablet	29/05/2017	Active
Corzyna Add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists)	ranolazine 500 mg and 1000 mg extended-release tablets	04/03/2021	Active
Cabometyx For advanced hepatocellular carcinoma (HCC) in patients who have previously been treated	cabozatinib 20 mg, 40 mg and 60 mg tablet	29/12/2021	First Review Completed
Cabometyx For the treatment of adult patients with advanced renal cell carcinoma who have received prior therapy	cabozatinib 20 mg, 40 mg and 60 mg tablet	29/12/2021	First Review Completed
Cosentyx Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy	secukinumab 150 mg/mL subcutaneous solution	30/08/2016	First Review Completed
Cosentyx Psoriatic arthritis	secukinumab 150 mg/mL subcutaneous solution	05/04/2018	First Review Completed
Cosentyx For the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy	secukinumab 150 mg/mL subcutaneous solution	28/03/2018	First Review Completed
Cosentyx For the treatment of adult patients with ankylosing spondylitis (AS)	secukinumab 150 mg/mL subcutaneous solution	06/11/2020	Active
Cotellic For the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation	cobimetinib 20 mg tablet	05/04/2018	First Review Completed
Coversyl Plus HD Hypertension	perindopril erbumine/indapamide 8 mg/2.5 mg tablet	29/04/2010	First Review Completed
Creon Minimicrospheres 35 Pediatric and adult patients for the treatment of pancreatic exocrine insufficiency (PEI) attributed to cystic fibrosis, chronic pancreatitis, or any other medically defined pancreatic disease that might require pancreatic enzyme therapy)	lipase/amylase/protease 35000/35700/2240 units, capsule	29/10/2021	First Review Completed
Cresemba For the treatment of invasive aspergillosis and invasive mucormycosis according to clinical criteria	isavuconazole sulfate 100 mg capsule	04/03/2020	First Review Completed
Crysvita For the treatment of X-linked hypophosphatemia (XLH) according to clinical criteria.	burosumab 10 mg/mL, 20 mg/mL and 30 mg/mL solution for subcutaneous injection	21/12/2021	First Review Completed
Cubicin For the treatment of patients with cSSSI or SAB/SARIE MRSA infections	daptomycin 500 mg/10 mL injection	04/01/2012	First Review Completed
Cubicin For the treatment of patients with Staphylococcus aureus (SA) bloodstream infection including right-sided SA infective endocarditis infection caused by MRSA who are intolerant, contraindicated or have failed to respond adequately to vancomycin	daptomycin 500 mg/10 mL injection	24/11/2015	First Review Completed
Cyramza As a single agent or in combination with paclitaxel for the treatment of patients with advanced advanced or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma, with disease progression on or after prior platinum and fluoropyrimidine chemotherapy	ramucirumab 10 mg/mL solution	06/06/2017	First Review Completed
Cystadrops The treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.	cysteamine HCl 0.37 % w/w ophthalmic solution	07/06/2019	Active
Camzyos For the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) Class II-III in adult patients	MAVACAMTEN 2.5 mg, 5 mg, 10 mg and 15 mg capsule	12/12/2022	Active
Daklinza Treatment of chronic Hepatitis C infections in combination with other agents	dalatasvir 30 mg and 60 mg tablet	15/06/2018	First Review Completed
Darzalex For the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are refractory to both a PI and an IMiD	daratumumab 100 mg/5 mL and 400 mg/20 mL solution for infusion	21/03/2017	Active
Darzalex Indicated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.	daratumumab 100 mg/5 mL and 400 mg/20 mL solution for infusion	21/03/2019	First Review Completed
Darzalex Darzalex (daratumumab) in combination with bortezomib, melphalan and prednisone for the treatment of newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant	daratumumab 100 mg/5 mL and 400 mg/20 mL solution for infusion	01/04/2019	Active
Darzalex In combination with lenalidomide and dexamethasone, for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.	daratumumab 100 mg/5 mL and 400 mg/20 mL solution for infusion	06/11/2019	Active
Darzalex SC – In combination with lenalidomide and dexamethasone (DRd), or with bortezomib, melphalan and prednisone (DVMP), for the treatment of patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) – In combination with lenalidomide and dexamethasone (DRd), or bortezomib and dexamethasone (DVd), for the treatment of patients with multiple myeloma who have received at least one prior therapy (RRMM).	daratumumab 120 mg/mL subcutaneous injection (new dosage form)	27/11/2020	Active
Daurismo In combination with low-dose cytarabine, for the treatment of newly diagnosed and previously untreated acute myeloid leukemia (AML) in adult patients, who are age â‰¥75 years or who are not eligible to receive intensive induction chemotherapy.	glasdegib maleate 25 mg tablet	18/12/2020	Active
Emgality For the preventative treatment of migraine in adults who have at least four migraine days per month and have experienced an inadequate response, intolerance, or contraindication to at least two prophylactic migraine medications	GALCANEZUMAB 120 mg/mL SC solution, single use prefilled syringe and single use prefilled pen	01/12/2022	First Review Completed
Daxas Maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis	roflumilast 500 mcg film-coated tablet	17/05/2012	Reconsideration Completed
DDAVP MELT Central diabetes insipidus and primary nocturnal enuresis	desmopressin acetate 240 mcg tablet	30/06/2010	First Review Completed
Delstrigo Indicated as a complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults without past or present evidence of viral resistance to doravirine, lamivudine, or tenofovir.	doravirine/lamivudine/tenofovir disoproxil fumarate 100 mg/300 mg/300 mg tablet	31/10/2019	First Review Completed
Descovy In combination with other antiretrovirals (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 12 years of age and older	emtrictabine/tenofovir alafenamide 200 mg/10 mg and 200 mg/25 mg tablet	31/03/2017	Active
Dexedrine Spansule SRC For treatment of attention deficit hyperactivity disorder and narcolepsy	dextroamphetamine sulfate 10 mg and 15 mg sustained-release capsule	27/06/2013	First Review Completed
Diacomit In conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet syndrome)	stiripentol 250 mg and 500 mg capsule	30/07/2015	First Review Completed
Diamicron MR Diabetes mellitus	gliclazide 60 mg MR tablet	26/07/2011	First Review Completed
Dificid For the treatment of Clostridium difficile infection (CDI) in adults â‰¥ 18 years of age	fidaxomicin 200 mg FC tablet	16/01/2014	First Review Completed
Diovan-HCT Hypertension	valsartan/hydrochlorothiazide 320 mg/12.5 mg and 320 mg/25 mg tablet	25/02/2009	First Review Completed
Dovato For the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 40 kg.	dolutegravir & lamivudine 50 mg & 300 mg tablet	31/01/2020	First Review Completed
Dovobet Gel Mild to moderate plaque psoriasis vulgaris on the body in patients 18 years and older for up to 8 weeks	calcipotriol & betamethasone dipropionate 50 mcg/g / 0.5 mg/g topical gel	27/05/2014	First Review Completed
Doptelet For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment	AVATROMBOPAG 20 mg tablet	14/12/2022	Active
Duaklir Genuair Long-term maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema	formoterol fumarate dehydrate & aclidinium bromide 12 ÂµG/ACT & 400 ÂµG/ACT inhalation powder	29/02/2016	First Review Completed
Duobrii For improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis.	halobetasol propionate and tazarotene 0.01 % & 0.045% lotion	31/01/2022	First Review Completed
Duodopa Parkinson’s disease	levodopa/carbidopa 20 mg/mL and 5 mg/mL gel	23/06/2014	Reconsideration Completed
DuoTrav Ocular hypertension and open-angle glaucoma	travoprost/timolol maleate 0.004 % and 0.5 % ophthalmic solution	03/11/2009	First Review Completed
Dupixent For the treatment of atopic dermatitis for patients who meet clinical criteria.	dupilumab 150 mg/mL & 200 mg/1.14 mL solution for subcutaneous injection	06/05/2021	First Review Completed
Dupixent As an add-on maintenance treatment in patients aged 12 years and older with severe asthma with a type 2/eosinophilic phenotype or oral corticosteroid dependent asthma.	dupilumab 300 mg prefilled syringe and 200 mg prefilled syringe, solution for subcutaneous injection	21/01/2021	Active
Dupixent For the treatment of patients aged 12 years and older with moderate-to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids.	dupilumab 150 mg/mL & 200 mg/1.14mL solution for subcutaneous injection	24/04/2020	Active
Dupixent For the treatment of patients aged 12 years and older with moderate-to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.	dupilumab New Format: 150 mg/1mL prefilled pen, solution for subcutaneous injection in 2mL prefilled pen	03/12/2021	First Review Completed
Dupixent For the treatment of atopic dermatitis for patients who meet clinical criteria	dupilumab 150 mg/mL solution for subcutaneous injection	06/05/2021	First Review Completed
Dupixent For the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who meet specified clinical criteria	DUPILUMAB 200 mg/1.14 mL (175 mg/mL) pre-filled pen	01/12/2022	First Review Completed
Duragesic Mat Opioid analgesic	fentanyl 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr transdermal patch	29/04/2010	First Review Completed
Dayvigo For the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance.	LEMBOREXANT 5 mg and 10 mg tablets	16/08/2022	Active
Dymista Symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptomsin adults and adolescents aged 12 years and older for whom monotherapy with either antihistamines or intranasal corticosteroids is not considered sufficient	fluticasone propionate & azelastine HCl 50 mcg & 137 mcg (per actuation) spray, metered dose (nasal)	24/11/2015	First Review Completed
Dysport Therapeutic For the symptomatic treatment of focal spasticity affecting the upper limbs in adults.	abobotulinumtoxinA 300 units/vial and 500 units/vial IM lyophilized powder for solution for injection	20/09/2018	First Review Completed
Dysport Therapeutic To reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults.	abobotulinumtoxinA 300 units/vial and 500 units/vial IM lyophilized powder for solution for injection	20/09/2018	First Review Completed
Dysport Therapeutic For the treatment of lower limb spasticity in pediatric patients 2 years of age and older.	abobotulinumtoxinA 300 and 500 units per vial	20/09/2018	First Review Completed
Edarbi For the treatment of mild to moderate essential hypertension	azilsartan medoxomil 40 mg and 80 mg tablet	02/05/2014	First Review Completed
Edarbyclor As initial therapy in patients with severe essential hypertension for whom the benefit of a prompt blood pressure reduction exceeds the risk of initiating combination therapy	azilsartan medoxomil/chlorthalidone 40 mg/12.5 mg, 80 mg/12.5 mg and 40 mg/25 mg tablet	25/03/2014	First Review Completed
Edurant Treatment of HIV-1 infection in antiretroviral treatment-naÃ¯ve adult patients	rilpivirine hydrochloride 25 mg tablet	19/07/2012	First Review Completed
Effient, Pre-Notice of Compliance Prevention of atherothrombotic events in patients with acute coronary syndrome (ACS)	prasugrel hydrochloride 10 mg tablet	19/10/2011	Reconsideration Completed
Egrifta The treatment of excess visceral adipose tissue (VAT) in treatment experienced adult HIV infected patients with lipodystrophy	tesamorelin 1 mg/vial powder for solution	13/06/2016	Active
Elelyso Long-term enzyme replacement therapy (ERT) for adults with a confirmed diagnosis of Type 1 Gaucher disease; may also be used in pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease, and for the haematological manifestations in pediatric patients with a confirmed diagnosis of Type 3 Gaucher disease.	taliglucerase alfa 200 units (per vial) powder for solution (intravenous)	22/03/2016	First Review Completed
Eliquis Treatment of venous thromboembolic (VTE) events (deep vein thrombosis [DVT], pulmonary embolism [PE]) and prevention of recurrent DVT and PE	apixaban 2.5 mg and 5 mg FC tablet	24/11/2015	First Review Completed
Eliquis For the prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective knee or hip replacement surgery	apixaban 2.5 mg FC tablet	24/11/2015	First Review Completed
Eliquis Prevention of stroke and systemic embolism in patients with atrial fibrillation	apixaban 2.5 mg and 5 mg tablet	22/08/2013	First Review Completed
Eloxatin Metastatic colorectal cancer	oxaliplatin 50 mg/10 mL, 100 mg/20 mL and 200 mg/40 mL solution	05/07/2011	First Review Completed
Eloxatin As part of the FOLFIRINOX regimen for the treatment of metastatic pancreatic cancer	oxaliplatin 50 mg/10 mL, 100 mg/20 mL and 200 mg/40 mL solution	04/01/2012	First Review Completed
Elonox, Elonox HP Anticoagulant/ Antithrombotic Agent	ENOXAPARIN SODIUM 30 mg /0.3 mL, 40 mg /0.4 mL, 60 mg /0.6 mL, 80 mg /0.8 mL, 100 mg /1.0 mL, 120 mg /0.8 mL & 150 mg /1.0 mL SC solution	05/12/2022	Active
Emerade For the emergency treatment of anaphylactic reactions in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.	epinephrine 0.15 mg, 0.3 mg and 0.5 mg solution for injection in pre-filled pen	04/10/2019	Active
Enbrel SureClick Auto Injector Plaque psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, juvenile idiopathic arthritis	etanercept 50 mg/mL pre-filled syringe	19/10/2011	First Review Completed
Enerzair Breezhaler For once-daily maintenance treatment of asthma in patients aged 12 years and older with reversible obstructive airways disease.	indacaterol acetate/glycopyrronium bromide/mometasone 150 mcg/50 mcg/80 mcg capsule for inhalation	28/02/2022	First Review Completed
Enspryng As monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients who are anti-aquaporin 4 (AQP4) seropositive	SATRALIZUMAB 120 mg/mL SC solution	22/12/2020	Active
Enstilar Topical treatment of psoriasis vulgaris in adults for up to 4 weeks	betamethasone (as diproprionate) & calcipotriol (as monohydrate) 0.5 mg/g & 50 mcg/g aerosol foam (topical)	24/10/2018	First Review Completed
Entresto Addition to the existing criteria: Initiation of sacubitril/valsartan may be considered in patients stabilized from an ADHF hospitalization without prior exposure to angiotensinconverting enzyme inhibitor or angiotensin II receptor blocker.	SACUBITRIL & VALSARTAN 24.3 mg/ 25.7 mg, 48.6 mg/ 51.4 mg and 97.2 mg/ 102.8 mg tablet	18/12/2020	Active
Entresto For the treatment of heart failure with reduced ejection fraction (HFrEF) in patients with NYHA Class II or III, to reduce the incidence of cardiovascular death and heart failure hospitalisation	sacubitril & valsartan 24.3 mg/25.7 mg, 48.6 mg/51.4 mg, 97.2 mg/102.8 mg FC tablet	20/04/2017	First Review Completed
Enhertu For the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received at least one prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy.	TRASTUZUMAB DERUXTECAN 100 mg/vial IV, powder for concentrate for solution for infusion	08/08/2022	Active
Entyvio For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a TNFÎ± 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 TNFÎ± antagonist	vedolizumab 300 mg/vial powder for solution	20/04/2017	First Review Completed
Entyvio For patients with moderately to severely active Crohn’s disease (CD)	vedolizumab 300 mg/vial powder for solution	20/04/2017	First Review Completed
Entyvio New subcutaneous presentation: For the treatment of adults with moderately to severely active CD.	vedolizumab 108 mg / 0.68 mL SC solution (prefilled pen and prefilled syringe)	11/01/2022	First Review Completed
Envarsus PA For the prophylaxis of organ rejection in allogenic kidney or liver transplant adult patients in combination with other immunosuppressants.	tacrolimus 0.75 mg, 1 mg, and 4 mg prolonged-release tablets	30/09/2020	First Review Completed
Epclusa For the treatment of chronic hepatitis C virus (HCV) infection	sofosbuvir & velpatasvir 400 mg & 100 mg tablet	13/03/2017	First Review Completed
Epuris Severe Nodular and/or Inflammatory Acne, Acne Conglobata and Recalcitrant Acne	isotretinoin 10 mg, 20mg, 30mg and 40mg capsule	20/02/2014	First Review Completed
Erbitux Initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck	cetuximab 2 mg/mL injection	17/04/2012	First Review Completed
Erbitux EGFR-expressing metastatic colorectal carcinoma in patients who are refractory or intolerant to other irinotecan-based regimens	cetuximab 2 mg/mL injection	16/10/2009	First Review Completed
Erelzi For reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in adult patients with psoriatic arthritis (PsA). ERELZI can be used in combination with methotrexate in adult patients who do not respond adequately to methotrexate alone.	etanercept 50 mg/mL SensoReady Pen, 50 mg/mL prefilled syringe, and 25 mg/0.5mL prefilled syringe SC solution for injection	01/04/2019	First Review Completed
Erelzi For treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy” and “treatment of pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy. Data on safety and efficacy are limited in the age group 4 to 6 years.	etanercept 50 mg/mL solution for injection in a prefilled syringe and prefilled autoinjector, 25 mg/0.5 mL solution for injection in a prefilled syringe	30/092020	First Review Completed
Erelzi For: - treatment of moderately to severely active rheumatoid arthritis (RA) in adults. Treatment is effective in reducing the signs and symptoms of RA, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function. Erelzi can be initiated in combination with methotrexate (MTX) in adult patients or used alone. - reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Erelzi has not been studied in children less than 4 years of age. - reducing signs and symptoms of active ankylosing spondylitis (AS).	etanercept 50 mg/ mL solution injection	22/03/2018	First Review Completed
Eretzi Treatment of adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Treatment of pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy. Data on safety and efficacy are limited in the age group 4 to 6 years.	etanercept 50 mg/mL solution for injection in a prefilled syringe and prefilled autoinjector, 25 mg/0.5 mL solution for injection in a prefilled syringe	30/09/2020	First Review Completed
Erivedge For the treatment of adult patients with metastatic basal cell carcinoma or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy	vismodegib 150 mg capsule	22/04/2014	First Review Completed
Erleada For the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC)	apalutamide 60 mg tablet	31/08/2020	First Review Completed
Erleada For the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC)	apalutamide 60 mg tablet	18/11/2021	First Review Completed
Esbriet For the treatment of mild to moderate idiopathic pulmonary fibrosis in adults	pirfenidone 267 mg capsule	21/08/2014	First Review Completed
Esbriet For the treatment of mild to moderate idiopathic pulmonary fibrosis in adults	pirfenidone 267 mg and 801 mg tablet	05/04/2018	First Review Completed
Esbriet For the treatment of idiopathic pulmonary fibrosis (IPF) in adults	pirfenidone 267 mg and 801 mg tablet	06/20/2018	First Review Completed
Eucrisa For topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.	crisaborole 2 % Ointment for topical use	16/11/2018	Active
Evenity The treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture	romosozumab 90 mg /mL (105 mg/1.17 mL)	08/04/2021	Active
Evrysdi For the treatment of spinal muscular atrophy according to clinical criteria.	risdiplam 0.75 mg/mL powder for solution	28/03/2022	First Review Completed
Entuzity KwikPen To improve glycemic control in adults and children with diabetes mellitus requiring more than 200 units of insulin per day.	INSULIN INJECTION HUMAN BIOSYNTHETIC 500 units/mL solution for injection, prefilled pen	29/04/2022	First Review Completed
Extavia Multiple sclerosis	interferon beta-1b 0.3 mg/vial powder for solution	21/03/2011	First Review Completed
Eylea For the treatment of neovascular (wet) age-related macular degeneration (AMD)	aflibercept 40 mg/mL/solution for intravitreal injection	04/08/2015	First Review Completed
Eylea For the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion	aflibercept 40 mg/mL/solution for intravitreal injection	04/08/2015	First Review Completed
Eylea Treatment of diabetic macular edema	aflibercept 40 mg/mL/solution for intravitreal injection	04/08/2015	First Review Completed
Eylea The treatment of visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO)	aflibercept 2 mg solution for intravitreal injection	31/03/2017	First Review Completed
Eylea Indication: – the treatment of neovascular (wet) age-related macular degeneration (AMD) – the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) – the treatment of visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) – the treatment of diabetic macular edema (DME).	aflibercept 40 mg/mL solution for intravitreal injection	31/05/2021	First Review Completed
Fampyra For the symptomatic improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (EDSS 3.5-7)	fampridine 10 mg SR tablet	20/09/2013	Second Review Completed
Fampyra Symptomatic improvement of walking in adult patients with multiple sclerosis with walking disability	fampridine 10 mg SR tablet	30/07/2015	File Closed
Fasenra For add-on maintenance treatment of adult patients with severe eosinophilic asthma who are inadequately controlled with high-dose ICS and one or more additional controller(s) (e.g. LABA), if one of the following clinical criteria are met 1.Blood eosinophil count â‰¥300 cells/ÂµLand have experienced twoor more clinically significant asthma exacerbationsn the past 12 months, or 2.Blood eosinophil count â‰¥150cells/ÂµLand are treated chronically with OCS.	benralizumab 30 mg/mL solution for subcutaneous injection	25/07/2018	Active
Fasenra Pen As an add-on maintenance treatment of adult patients with severe eosinophilic asthma.	benralizumab 30 mg/mL SC solution - New Presentation: Single Use Prefilled Auto-Injector	12/04/2021	First Review Completed
Faslodex Locally advanced or metastatic breast cancer in postmenopausal women	fulvestrant 50 mg/mL injection	10/07/2009	First Review Completed
Faslodex For the hormonal treatment of non-visceral locally advanced or metastatic HER2- breast cancer in postmenopausal women, regardless of age, who have not been previously treated with endocrine therapy	fulvestrant 50 mg/mL intramuscular solution injection	01/03/2018	Active
Fentora For the treatment of breakthrough pain (transient, incremental pain over and above baseline) in patients with advanced cancer	fentanyl citrate 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg tablet	06/07/2016	File Closed
Fentora For the management of breakthrough pain in advanced cancer patients 18 years of age or older with the underlying pain adequately managed using a continuous opioid therapy (persistent baseline cancer pain)	fentanyl citrate 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg tablet	22/03/2017	Active
Ferriprox For the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate	deferiprone 1000 mg tablet	28/03/2017	First Review Completed
Ferriprox For the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate	deferiprone 100 mg/mL oral solution	15/06/2018	First Review Completed
Ferriprox For the treatment of patients with transfusional iron overload due to sickle cell disease or other anemias	deferiprone 100 mg/mL solution (oral) & 1000 mg tablet	16/09/2022	Active
Fiasp For the treatment of adult patients with diabetes mellitus who require mealtime insulin for the control of hyperglycemia	insulin aspart 100 U/mL vial, 100 U/mL penfill cartridge and 100 U/mL pre-filled pen	28/05/2018	Active
Fibristal Treatment of moderate to severe signs and symptoms of uterine fibroids in adult women	ulipristal acetate 5 mg tablet	29/02/2016	First Review Completed
Fibristal Treatment of moderate to severe signs and symptoms of uterine fibroids in adult women of reproductive age, who are eligible for surgery. The duration of treatment is two courses, with each course limited to 3 months	ulipristal acetate 5 mg tablet	15/06/2018	First Review Completed
Finacea Topical treatment of mild to moderate rosacea	azelaic acid 15% topical gel	08/09/2011	First Review Completed
Firazyr For the treatment of acute attacks of hereditary angioedema (HAE) in adults with C1-esterase inhibitor deficiency	icatibant acetate 10 mg/mL SC solution	24/11/2015	First Review Completed
Firmagon Advanced hormone-dependent prostate cancer	degarelix acetate 80 mg/vial and 120 mg/vial powder for solution	21/03/2011	First Review Completed
Fluanxol Depot Schizophrenia	flupenthixol decanoate 20 mg/mL solution in 1mL ampoule and 100 mg/mL solution in 1mL ampoule	27/05/2009	First Review Completed
Fludara For the treatment of patients with previously untreated CLL when used in combination with rituximab	fludarabine 10 mg tablet	26/07/2011	First Review Completed
Folotyn For the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) according to clinical criteria.	pralatrexate 20 mg/mL IV solution	17/07/2020	First Review Completed
Foquest Treatment of attention deficit/hyperactivity disorder (ADHD) in adults (>= 18 years of age)	METHYLPHENIDATE HYDROCHLORIDE 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg, and 100 mg CR capsule	03/05/2019	File Closed
Foquest For the treatment of attention deficit hyperactivity disorder in patients aged 6 years and older	METHYLPHENIDATE HYDROCHLORIDE 25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg, 100 mg CR capsule	23/11/2022	Active
Fora Test N' Go Test Strip To measure the concentration of glucose in the blood	GDH-FAD glucose dehydrogenase	15/06/2018	First Review Completed
Forteo Osteoporosis (glucocorticoid – induced)	teriparatide 250 mcg/mL injection	27/05/2014	Reconsideration Completed
Forxiga For use in patients with type 2 diabetes mellitus to improve glycemic control	dapagliflozin 5 mg and 10 mg tablet	15/06/2018	First Review Completed
Forxiga For the treatment of patients with type 2 diabetes mellitus to improve glycemic control when added on to metformin and a sulfonylurea for patients with inadequate glycemic control on metformin and a sulfonylurea and for whom insulin is not an option	dapagliflozin 5 mg and 10 mg tablet	15/06/2018	First Review Completed
Forxiga In adults, as an adjunct to standard of care therapy, for the treatment of heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure and urgent heart failure visit.	dapagliflozin 5 mg and 10 mg tablet	17/12/2021	First Review Completed
Forxiga For use in patients with type 2 diabetes mellitus to improve glycemic control	dapagliflozin 5 mg and 10 mg tablet	15/06/2018	First Review Completed
Forxiga For the treatment of patients with type 2 diabetes mellitus to improve glycemic control when added on to metformin and a sulfonylurea for patients with inadequate glycemic control on metformin and a sulfonylurea and for whom insulin is not an option	dapagliflozin 5 mg and 10 mg tablet	15/06/2018	First Review Completed
Forxiga In adults, as an adjunct to standard of care therapy, for the treatment of heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular (CV) death, hospitalization for heart failure and urgent heart failure visit.	dapagliflozin 5 mg and 10 mg tablet	17/12/2021	First Review Completed
Fosavance Osteoporosis in postmenopausal women and osteoporosis in men	alendronate sodium/cholecalciferol 70 mg/140 Âµg tablet	16/06/2009	First Review Completed
Fragmin Anticoagulation	dalteparin sodium 7500IU/0.3 mL pre-filled safety syringe	17/02/2012	First Review Completed
Fragmin Anticoagulation	dalteparin sodium 2,500 IU/mL solution for injection	24/11/2015	First Review Completed
Fragmin Thromboprophylaxis in conjunction with surgery; Treatment of acute deep venous thrombosis; Unstable coronary artery disease (UCAD), i.e., unstable angina and non-Q-wave myocardial infarction; Prevention of clotting in the extracorporeal system during hemodialysis and hemofiltration in connection with acute renal failure or chronic renal insufficiency; Extended treatment of symptomatic venous thromboembolism to prevent recurrence of venous thromboembolism in patients with cancer; Reduction of deep vein thrombosis (DVT) in hospitalized patients with severely restricted mobility during acute illness.	dalteparin sodium 16,500 IU / 0.66 mL prefilled syringe	26/02/2021	First Review Completed
Fragmin 3500 IU (Anti-Factor XA)/0.28mL For anticoagulation/ antithrombotic therapy	dalteparin sodium 3500 unit/0.28mL single dose prefilled syringes	26/06/2018	First Review Completed
FreeStyle Libre 2 Flash Glucose Monitoring System For measuring interstitial fluid glucose levels in people aged 4 years and older with diabetes mellitus		30/11/2021	First Review Completed
FreeStyle Precision Blood Glucose Test Strips To measure the concentration of glucose in the blood	glucose dehydrogenase	21/11/2014	First Review Completed
Fulphila To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti- neoplastic drugs.	pegfilgrastim 6 mg (10 mg/mL) SC solution for injection	08/11/2019	Active
Fycompa As adjunctive therapy in the management of partial-onset seizures, in adult patients with epilepsy who are not satisfactorily controlled with conventional therapy	perampanel 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablet	20/02/2014	First Review Completed
Fycompa As an adjunctive therapy for the management of primary generalized tonic-clonic seizures in adults	perampanel 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablet	29/07/2016	Active
Givlaari For the treatment of acute hepatic porphyria (AHP) in adults.	GIVOSIRAN 189 mg/ mL SC Solution	01/12/2021	Active
Galafold For long-term treatment of adult and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (Î±-galactosidase A deficiency) and who have an amenable mutation.	migalastat HCl 123 mg capsule	13/05/2019	First Review Completed
Galexos Treatment of chronic hepatitis C	simeprevir sodium 150 mg capsule	29/09/2014	First Review Completed
Gazyva In combination with chlorambucil for previously untreated chronic lymphocytic leukaemia where fludarabine-based therapy is considered inappropriate	obinutuzumab 25 mg/mL IV solution	04/08/2015	First Review Completed
Gazyva In combination with chemotherapy for the treatment of patients with follicular lymphoma who relapsed after, or are refractory to, a rituximab containing regimen	obinutuzumab 25 mg/mL IV solution	22/11/2018	First Review Completed
Gazyva GAZYVA, in combination with chemotherapy followed by GAZYVA monotherapy, for the treatment of patients with previously untreated follicular lymphoma.	obinutuzumab 25 mg/mL Concentrate for Solution for Infusion	06/05/2022	First Review Completed
GE200 Glucose Test Strips To measure the concentration of glucose in the blood	FAD-Glucose Dehygrogenase (FAD-GDH) N/A	24/06/2015	First Review Completed
Gelnique For the treatment of overactive bladder	oxybutynin chloride 100 mg/g topical gel	23/04/2013	Reconsideration Completed
Genotropin GoQuick Genotropin MiniQuick For replacement of endogenous growth hormone in adults with growth hormone deficiency	somatropin 5.3 mg and 12 mg pre-filled pen, GoQuick 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg and 2 mg pre-filled syringe, MiniQuick	21/08/2014	First Review Completed
Genotropin GoQuick Genotropin MiniQuick The treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed	somatropin 5.3 mg and 12 mg pre-filled pen, GoQuick 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg and 2 mg pre-filled syringe, MiniQuick	21/08/2014	First Review Completed
Genotropin GoQuick Genotropin MiniQuick The long-term treatment of children who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency (GHD))	somatropin 5.3 mg and 12 mg pre-filled pen, GoQuick 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg and 2 mg pre-filled syringe, MiniQuick	21/08/2014	First Review Completed
Genvoya As a complete regimen for the treatment- naÃ¯ve and virologically suppressed HIV-1 infected adults and pediatric patients 12 years of age and older (and weighing > 35 kg) and with no known mutations associated with resistance to the individual components of GENVOYA	elvitegravir & cobicistat & emtricitabine & tenofovir alafenamide 150 mg & 150 mg & 200 mg & 10 mg tablet	20/04/2017	First Review Completed
Gilenya, Post-Notice of Compliance For the treatment of patients with the relapsing-remitting form of multiple sclerosis (MS)	fingolimod HCl 0.5 mg capsule	23/04/2013	First Review Completed
Giotrif As monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor naÃ¯ve patients with metastatic (including cytologically proven pleural effusion) adenocarcinoma of the lung with activating EGFR mutation(s)	afatinib dimaleate 20 mg, 30 mg and 40 mg tablet	21/08/2014	First Review Completed
Glatect Treatment of ambulatory patients with relapsing remitting multiple sclerosis, including patients who have experienced a single demyelinating event and have lesions typical of multiple sclerosis on brain MRI: to decrease the frequency of clinical exacerbations; and to reduce the number and volume of active brain lesions identified on Magnetic Resonance Imaging (MRI) scans.	glatiramer acetate 20 mg/mL pre-filled syringe for subcutaneous injection	20/09/2018	First Review Completed
Gleevec Adjuvant treatment of gastrointestinal stromal tumors	imatinib mesylate 100 mg and 400 mg tablet	27/04/2012	Reconsideration Completed
Glucagen, Glucagen Hypokit Treatment of severe hypoglycemic reaction	glucagon 1 mg/vial powder for solution	04/01/2012	First Review Completed
GlucoDr. Auto Test Strip To measure the concentration of glucose in the blood	glucose dehydrogenase (FAD/GDH)	04/04/2018	First Review Completed
Grastek For the treatment of signs and symptoms of grass allergy	standardized allergenic extract, Timothy grass (phleum pratense) 2800 BAU sublingual tablet	22/01/2015	First Review Completed
Grastofil To reduce infections and/or the duration of neutropenia and related sequelae in the following patient groups: cancer patients receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia; cancer patients receiving myeloablative chemotherapy followed by bone marrow transplantation; patients with severe chronic neutropenia; and patients with HIV infection. Grastofil is also indicated for cancer patients undergoing peripheral blood progenitor cell collection and therapy	filgrastim 300 mcg/ 0.5 mL SC or IV Solution	28/03/2017	First Review Completed
Hadlima and Hadlima PushTouch Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult Crohn’s Disease, Ulcerative Colitis, Hidradenitis Suppurativa, Plaque Psoriasis, Adult Uveitis, and Pediatric Uveitis.	adalimumab 40 mg in 0.8 mL solution for subcutaneous injection (prefilled syringe and autoinjector)	29/03/2021	First Review Completed
Halaven For metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease	eribulin mesylate 0.5 mg/mL IV solution	17/01/2013	First Review Completed
Harvoni For the treatment of chronic hepatitis C virus (CHC) genotype 1 infection in adults	ledipasvir/sofosbuvir 90 mg/400 mg tablet	30/06/2021	First Review Completed
Hemangiol For the treatment of proliferating infantile hemangioma requiring systemic therapy: Life- or function-threatening hemangioma, Ulcerated hemangioma with pain and/or lack of response to simple wound care measures, and Hemangioma with a risk of permanent scarring or disfigurement	propranolol 3.75 mg/ mL oral solution	22/11/2019	First Review Completed
Heparin Anticoagulant	heparin sodium 1000 U/mL & 10000 U/mL IV injection solution	25/06/2018	File Closed
Heparin Sodium Injection USP For prophylaxis and treatment of venous thrombosis and its extension, prophylaxis and treatment of pulmonary embolism, prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation, prevention of clotting in arterial and heart surgery, prophylaxis and treatment of peripheral arterial embolism, anticoagulant use in blood transfusions, extracorporeal circulation and dialysis procedures and diagnosis and treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation)	heparin sodium 1000 U/mL, 5000 U/mL and 10000 U/mL solution	26/11/2015	File Closed
Herceptin Metastatic breast cancer beyond progression	trastuzumab 440 mg/ vial/ 20 mL/ vial powder for solution	17/01/2012	Reconsideration Completed
Herceptin SC For use in the treatment of early and metastatic HER2-positive breast cancer patients.	trastuzumab 600 mg/5 mL solution for subcutaneous injection single dose vial	29/11/2018	Active
Herceptin, Pre-Notice of Compliance Advanced gastric cancer	trastuzumab 440 mg/ vial/ 20mL/ vial powder for solution	17/01/2012	First Review Completed
Herzuma For all eligible HER2 positive breast and gastric cancer (metastatic adenocarcinoma of the stomach or gastro-esophageal junction) patients	TRASTUZUMAB 440 mg/vial intravenous infusion	22/01/2020	First Review Completed
Herzuma Early Breast Cancer (EBC) Metastatic Breast Cancer (MBC) Metastatic Gastric Cancer (MGC)	TRASTUZUMAB 440 mg/vial IV powder for solution, kit	22/01/2020	First Review Completed
Herzuma HERZUMA can be used in combination with pertuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. For information on the use of HERZUMA in combination with pertuzumab and docetaxel, consult the Product Monograph for pertuzumab	TRASTUZUMAB 440 mg/vial IV powder for solution, kit and 150 mg/vial PWSO, IV	15/09/2022	First Review Completed
Holkira Pak For the treatment of hepatitis C virus (HCV) genotype 1	ombitasvir/ paritaprevir/ ritonavir & dasabuvir 12.5mg/ 75mg/ 50mg & 250 mg FC tablet	30/07/2015	First Review Completed
Hulio Biological Response Modifier	adalimumab 40 mg in 0.8 mL subcutaneous solution (prefilled syringe and prefilled pen)	29/03/2021	First Review Completed
Humalog Junior KwikPen For treatment of diabetes	insulin lispro 100 units/mL solution for injection, prefilled pen	20/09/2019	First Review Completed
Humalog Kwikpen For treatment of diabetes	insulin lispro 200 U/mL solution	25/06/2018	First Review Completed
Humalog KwikPen, Humalog Mix25 KwikPen, Humalog Mix50 KwikPen Diabetes, Type 1 & 2	insulin lispro 100 U/mL, 25 %/ 75 % and 50 %/ 50 % prefilled pen	19/05/2011	First Review Completed
Humira For treatment of fistulizing Crohn’s	adalimumab 40 mg/0.8 mL subcutaneous injection	05/07/2011	First Review Completed
Humira In combination with methotrexate, reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 to 17 years of age who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs)	adalimumab 40 mg/ 0.8 mL vial for pediatric use, 40 mg/ 0.8 mL pre-filled syringe and 40 mg/ 0.8 mL pre-filled pen	20/02/2014	First Review Completed
Humira For ulcerative colitis	adalimumab 40 mg/ 0.8 mL subcutaneous solution	29/03/2016	File Closed
Humira For the treatment of non-infections uveitis	adalimumab 40 mg/ 0.8 mL subcutaneous solution	26/11/2015	First Review Completed
Humira For the treatment of active moderate to severe Hidradenitis Suppurativa in adult patients who have not responded to conventional therapy (including systemic antibiotics)	adalimumab 40 mg/0.8 mL subcutaneous solution	05/04/2018	First Review Completed
Humira Treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy including corticosteroids, azathiprine and/or 6-MP or who are intolerant to such therapies	adalimumab 40 mg/ 0.8 mL subcutaneous solution	25/06/2018	First Review Completed
Humira Rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa, psoriasis, uveitis	adalimumab 40 mg/ 0.4 mL solution (subcutaneous) pre-filled syringe and 40 mg/ 0.4 mL solution (subcutaneous) pre-filled pen (new strength)	25/06/2018	First Review Completed
Humira For the treatment of pediatric patients in the following indications: Polyarticular juvenile idiopathic arthritis (JIA), Crohn’s disease, ulcerative colitis, non-infectious ocular inflammatory disease / uveitis.	adalimumab 20 mg/0.2 mL (100 mg/mL) SC solution for injection, (additional strength and format)	19/01/2021	First Review Completed
Hydromorph Contin For the relief of severe chronic pain requiring the prolonged use of an oral opioid preparation	hydromorphone hydrochloride 4.5 mg and 9 mg CR capsule	18/01/2012	First Review Completed
Hymark Easy Plus Self Monitoring Blood Glucose Test Strip To measure the concentration of glucose in the blood	glucose oxidase (aspergillus niger) 1.0 - 5.0 IU test strip	29/04/2011	First Review Completed
Hyrimoz Expansion of the indications: Pediatric CrohnÃ¢â‚¬â„¢s Disease - Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 13 to 17 years of age weighing â‰¥ 40 kg with severely active CrohnÃ¢â‚¬â„¢s disease and/or who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumour necrosis factor alpha antagonist. Hidradenitis Suppurativa - Treatment of active moderate to severe hidradenitis suppurativa in adult and adolescent patients (12 to 17 years of age weighing â‰¥ 30 kg) who have not responded to conventional therapy (including systemic antibiotics). Pediatric Uveitis - Treatment of chronic non-infectious anterior uveitis in pediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.	adalimumab 40 mg/ 0.8 mL and 20 mg/0.4 mL SC solution (autoinjector pen and prefilled syringe)	31/05/2022	First Review Completed
Ibavyr In combination with other agents for the treatment of chronic hepatitis C (CHC) in adults	ribavirin 400 mg and 600 mg tablet	05/05/2015	First Review Completed
Ibavyr In combination with other agents for the treatment of chronic hepatitis C (CHC) in adults	ribavirin 200 mg tablet	06/01/2016	First Review Completed
Ibrance For the treatment of patients with estrogen receptor (ER)– positive, human epidermal growth factor receptor 2 (HER 2)– negative, unresectable locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant according to clinical criteria	palbociclib 75 mg, 100 mg and 125 mg capsule	04/12/2020	First Review Completed
Ibrance For the treatment of patients with estrogen receptor (ER) – positive, human epidermal growth factor receptor 2 (HER 2)– negative, unresectable locally advanced or metastatic breast cancer according to clinical criteria	palbociclib 75 mg, 100 mg, 125 mg tablets	04/12/2020	First Review Completed
Iclusig Treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig is a BCR-ABL inhibitor that has activity against all clinically relevant BCR-ABL mutations, including the difficult-to-treat T315l mutation.	ponatinib HCl 15 mg and 45 mg tablet	25/06/2018	First Review Completed
Idacio Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult Crohn’s Disease, Pediatric Crohn’s Disease, Ulcerative Colitis, Hidradenitis Suppurativa, Plaque Psoriasis, Adult Uveitis, Pediatric Uveitis.	ADALIMUMAB 40 mg / 0.8 mL (50 mg/mL) SC solution, pen injector	29/03/2021	First Review Completed
Idacio Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Adult Crohn's Disease, Pediatric Crohn's Disease, Ulcerative Colitis, Hidradenitis Suppurativa, Plaque Psoriasis, Adult Uveitis, Pediatric Uveitis.	ADALIMUMAB 40 mg/ 0.8 mL (50 mg/mL) SC solution, prefilled syringe	29/10/2021	First Review Completed
Ideal Life Glucose Test Strip To measure the concentration of glucose in the blood	glucose oxidase	25/06/2018	First Review Completed
Idhifa For the treatment of adult patients with relapsed or refractory Acute Myeloid Leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.	enasidenib mesylate 50 mg 100 mg tablets	07/06/2019	Active
Ilaris For the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older	canakinumab 150 mg powder for solution	25/08/2016	Active
Ilaris For the ongoing management of Cryopyrin-Associated Periodic Syndromes	canakinumab 150 mg powder for solution	05/03/2018	Active
Iluvien For the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.	fluocinolone acetonide 0.19 mg Intravitreal implant	17/06/2019	Active
Intrarosa For treatment of postmenopausal vulvovaginal atrophy	PRASTERONE 6.5 mg vaginal ovule	02/02/2022	Active
Inqovi For treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups	DECITABINE / CEDAZURIDINE 35 mg/ 100 mg tablet	19/12/2022	First Review Completed
Inqovi For treatment of adult patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups	DECITABINE / CEDAZURIDINE 35 mg/100 mg tablet	06/12/2022	Active
Imbruvica Treatment of patients with chronic lymphocytic leukemia (CLL), including those with 17p deletion, who have received at least one prior therapy, or for the frontline treatment of patients with CLL with 17p deletion	ibrutinib 140 mg capsule	04/08/2015	First Review Completed
Imbruvica For the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL)	ibrutinib 140 mg capsule	25/06/2018	First Review Completed
Imbruvica Treatment of WaldenstrÃƒÂ¶m’s Macroglobulinemia (WM)	ibrutinib 140 mg capsule	28/05/2018	Active
Imbruvica For the treatment of patients with previously untreated Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) for whom fludarabine-based treatment is considered inappropriate	ibrutinib 140 mg capsule	13/03/2017	First Review Completed
Imfinzi For the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) according to clinical criteria.	DURVALUMAB 50 mg/mL intravenous infusion	22/01/2020	First Review Completed
Imfinzi In combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)	DURVALUMAB 50 mg/mL intravenous infusion	22/07/2022	First Review Completed
Imfinzi Treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine-based chemotherapy	DURVALUMAB 50 mg/mL solution (IV infusion)	28/12/2022	Active
Incivek Treatment of genotype 1 chronic hepatitis C	telaprevir 375 mg tablet	23/04/2014	Reconsideration Completed
Inclunox AND Inclunox HP – The prophylaxis of thromboembolic disorders (deep vein thrombosis) in patients undergoing: – orthopedic surgery of the hip or knee. In addition, Inclunox is indicated in hospital or after hospital discharge for long-term prevention of venous thromboembolic diseases following hip replacement surgery. – high risk abdominal, gynecological, or urological surgeries; – colorectal surgery. – The prophylaxis of deep vein thrombosis (DVT) in medical patients who are at moderate risk of DVT and who are bedridden due to moderate to severe acute cardiac insufficiency (NYHA Class III or IV heart failure), acute respiratory failure revealing or complicating chronic respiratory insufficiency not requiring ventilatory support and acute respiratory infections (excluding septic shock), who require short-term prophylaxis of deep vein thrombosis. – The prevention of thrombus formation in the extra – corporeal circulation during hemodialysis. – The treatment of deep vein thrombosis, with or without pulmonary embolism. – The treatment of unstable angina or non-Q-wave myocardial infarction, concurrently with ASA. – Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).	enoxaparin sodium 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL and 100 mg/mL AND 120 mg/0.8 mL and 150 mg/mL solution for injection	31/05/2021	First Review Completed
Ilumya For the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.	TILDRAKIZUMAB 100 mg/mL Injection Solution	28/02/2022	First Review Completed
Incruse Ellipta For long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema.	umeclidinium (as bromide) 62.5 mcg dry powder for oral inhalation	29/02/2016	First Review Completed
Inflectra For treatment of Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Plaque Psoriasis	infliximab 100 mg/vial lyophilized powder	11/30/2016	First Review Completed
Imvexxy For the treatment of postmenopausal moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy.	ESTRADIOL HEMIHYDRAYTE 4 mcg and 10 mcg insert vagina	24/01/2022	Active
Inflectra Crohn’s disease and ulcerative colitis	infliximab 100 mg/vial powder for solution	13/03/2017	First Review Completed
Inflectra Pediatric Croihn's disease and pediatric ulcerative colitis – For reducing signs and symptoms and for inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. – For reducing signs and symptoms, inducing and maintaining clinical remission and inducing mucosal healing in pediatric patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy (i.e., aminosalicylate and/or corticosteroid and/or an immunosuppressant).	infliximab 100 mg / vial lyophilized powder for solution (IV)	30/06/2020	Active
Inlyta Treatment of patients with metastatic renal cell carcinoma of clear cell histology after failure of prior systemic therapy with either a cytokine or the VEGFR-TKI, sunitinib	axitinib 1 mg and 5 mg tablet	16/01/2014	First Review Completed
Innohep Prevention of postoperative venous thromboembolism; Treatment of deep vein thrombosis and/or pulmonary embolism; Prevention of clotting in indwelling intravenous lines for haemodialysis	tinzaparin sodium 2,500 IU/0.25 mL prefilled syringe injection	20/08/2010	First Review Completed
Inrebic For the treatment of splenomegaly and/or disease related symptoms in adult patients with intermediate-2 or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, including patients who have been previously exposed to ruxolitinib.	fedratinib 100 mg capsules	08/09/2022	First Review Completed
Inspiolto Respimat For the long term, once daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema	tiotropium & olodaterol 2.5 mcg/2.5 mcg per actuation, inhalation solution	15/06/2018	First Review Completed
Inspra Post myocardial infarction	eplerenone 25 mg and 50 mg tablet	29/04/2010	First Review Completed
Inspra Heart failure, NYHA class ll	eplerenone 25 mg and 50 mg tablet	24/06/2015	First Review Completed
Intelence In combination with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in treatment-experienced adult patients who have failed prior therapy and have HIV-1 strains resistant to multiple antiretroviral agents, including NNRTIs	etravirine 200 mg tablet	04/05/2012	First Review Completed
Intuniv XR As monotherapy for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years	guanfacine hydrochloride 1 mg, 2 mg, 3 mg and 4 mg ER tablet	22/01/2015	First Review Completed
Intuniv XR For the treatment of attention deficit hyperactivity disorder, according to specified criteria	guanfacine hydrochloride 1 mg, 2 mg, 3 mg and 4 mg ER tablet	31/01/2020	First Review Completed
Invega Sustenna Schizophrenia	paliperidone palmitate 50 mg/0.5 mL, 75 mg/0.75 mL, 100 mg/1 mL and 150 mg/1.5 mL ER suspension	18/01/2012	First Review Completed
Invega Trinza Treatment of schizophrenia in adult patients	paliperidone (supplied as paliperidone palmitate) 175 mg/0.875 mL, 263 mg/1.315 mL, 350 mg/1.75 mL, 525 mg/ 2.625 mL suspension (extended release; intramuscular) prefilled syringe	22/03/2018	First Review Completed
Invokamet Type 2 diabetes	canagliflozin & metformin HCl 50 mg/500 mg, 50 mg/850 mg, 50 mg/1000 mg, 150 mg/500 mg, 150 mg/850 mg and 150 mg/1000 mg tablets	22/03/2017	Active
Invokana As an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus	canagliflozin 100 mg and 300 mg tablet	04/08/2015	First Review Completed
Iressa First-line treatment for locally advanced or metastatic non-small cell lung cancer	gefitinib 250 mg tablet	19/10/2011	Reconsideration Completed
Isentress As part of a HIV treatment regimen for treatment-naive adult patients	raltegravir potassium 400 mg tablet	22/04/2014	First Review Completed
Istodax For the treatment of patients with relapsed/refractory peripheral T-cell lymphoma	romidepsin 10 mg vial powder for intravenous solution	10/12/2015	First Review Completed
Izba For the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.	travoprost 0.003 % w/v ophthalmic aqueous solution	23/04/2019	First Review Completed
Jadenu For patients with chronic iron overload in transfusion-related anemia due to beta-thalassemia or sickle cell disease and for the treatment of chronic iron overload in transfusion dependent anemia in those with low-risk myelodysplastic syndrome or other rare anemias (e.g. Diamond Blackfan) in patents who have a contraindication or severe intolerance to deferoxamine	deferasirox 90 mg, 180 mg and 360 mg FC tablet	20/04/2017	First Review Completed
Jakavi The treatment of splenomegaly and/or its associated symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.	RUXOLITINIB 10 mg tablet	04/08/2015	File Closed
Jakavi The treatment of splenomegaly and/or its associated symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis.	RUXOLITINIB 5 mg, 15 mg and 20 mg tablet	19/09/2013	First Review Completed
Jakavi Control of hematocrit in adult patients with polycythemia vera (PV) resistant to or intolerant of a cytoreductive agent	RUXOLITINIB 5 mg, 10 mg, 15 mg, 20 mg tablet	25/06/2018	First Review Completed
Jakavi For the treatment of steroid refractory or dependent acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.	RUXOLITINIB 5 mg, 10 mg, 15 mg, 20 mg tablet	03/10/2022	Active
Jakavi Â For the treatment of chronic graft-versus-host disease (GVHD) in adults and pediatric patients aged 12 years and older who have inadequate response to corticosteroids or other systemic therapies.	RUXOLITINIB 5 mg, 10 mg, 15 mg and 20 mg tablets	03/10/2022	Active
Janumet Diabetes, Type 2	sitagliptin/metformin hydrochloride 500 mg/50 mg, 850 mg/50 mg and 1000 mg/50 mg tablet	17/02/2012	First Review Completed
Janumet XR Diabetes, Type 2	sitagliptin phosphate monohydrate and metformin hydrochloride 50 mg/1000 mg modified-release tablets	24/10/2014	First Review Completed
Janumet XR Diabetes, Type 2	sitagliptin phosphate monohydrate and metformin hydrochloride 50 mg/500 mg and 100 mg/1000 mg ER tablet	28/03/2017	First Review Completed
Januvia Diabetes, Type 2	sitagliptin phosphate monohydrate 25 mg and 50 mg tablet	19/09/2013	First Review Completed
Jardiance To improve glycemic control in adult patients with type 2 diabetes mellitus	empagliflozin 10 mg and 25 mg tablet	30/05/2016	First Review Completed
Jardiance Add-on combination in patients with established cardiovascular disease	empagliflozin 10 mg and 25 mg tablet	26/06/2018	First Review Completed
Jardiance For the treatment of chronic heart failure in adults, as an adjunct to standard of care therapy	empagliflozin 10 mg tablet	08/07/2022	Active
Jaydess For conception control	levonorgestrel 13.5 mg/unit intrauterine system	04/08/2015	First Review Completed
Jentadueto To improve glycemic control in adult patients with type 2 diabetes mellitus	linagliptin/metformin hydrochloride 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg tablet	25/03/2014	First Review Completed
Jetrea The treatment of symptomatic vitreomacular adhesion (VMA)	ocriplasmin 2.5 mg/mL solution for intravitreal injection	12/12/2014	First Review Completed
Jevtana, Post-Notice of Compliance For the treatment of patients with castration resistant metastatic prostate cancer	cabazitaxel 40 mg/mL intravenous solution	25/07/2012	First Review Completed
Jinarc Slow the progression of kidney enlargement in patients with autosomal dominant polycystic kidney disease (ADPKD).	tolvaptan 45 mg+15 mg, 60 mg+30 mg, 90 mg+30 mg tablet	10/06/2016	First Review Completed
Jorveza Induction of clinico-pathological remission in adults with eosinophilic esophagitis (EoE).	budesonide 1 mg orally disintegrating tablets	18/02/2020	Active
Jublia The topical treatment of mild to moderate onychomycosis (tinea unguium) of toenails without lunula involvement due to Trichophyton rubrum and Trichophyton mentagrophytes in immunocompetent adult patients.	efinaconazole 10% w/w topical solution	01/04/2019	Active
Jemperli Monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum containing regimen.	DOSTARLIMAB 500 mg/10 mL vial (50 mg/mL) IV solution	19/01/2022	Active
Kimmtrak For the treatment of human leukocyte antigen (HLA)-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (UM).	TEBENTAFUSP 100 mcg/0.5 mL IV solution	30/06/2022	Active
Juluca For the treatment of human immunodeficiency virus (HIV-1) infection in adults who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per mL).	dolutegravir and rilpivirine 50 mg and 25 mg tablet	23/04/2019	First Review Completed
Jurnista Moderate to severe chronic pain	hydromorphone hydrochloride 4 mg, 8 mg, 16 mg and 32 mg ER tablet	06/07/2011	Second Review Completed
Juxtapid As an adjunct to a low-fat diet and other lipid-lowering drugs, with or without LDL apheresis, to reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolemia (HoFH)	lomitapide (supplied as lomitapide mesylate) 5 mg, 10 mg, 20 mg capsule	30/11/2015	First Review Completed
Kadcyla For the treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab and taxane	trastuzumab emtansine 100 mg/160 mg IV powder for solution	27/05/2014	First Review Completed
Kadcyla For the adjuvant treatment of patients with HER2-positive early breast cancer, who have residual disease according to clinical criteria	trastuzumab emtansine 20 mg/mL powder for solution (100 mg/vial and 160 mg/vial)	27/01/2021	First Review Completed
Kaletra Human Immunodeficiency Virus (HIV) infection	lopinavir/ritonavir 100 mg/25 mg tablet	26/03/2009	First Review Completed
Kalydeco For the treatment of cystic in patients age 6years and older according to clinical criteria	ivacaftor 150 mg tablet	20/12/2019	First Review Completed
Kalydeco For the treatment of cystic fibrosis with mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene	ivacaftor 150 mg tablet	10/12/2015	First Review Completed
Kalydeco Treatment of cystic fibrosis (CF) in patients age 18 years and older with an R117H mutation in the CFTR gene	ivacaftor 150 mg tablet	29/02/2016	Active
Kanjinti For the treatment of Early Breast Cancer (EBC), Metastatic Breast Cancer (MBC) and Metastatic Gastric Cancer (MGC) of the stomach or gastro-esophageal junction according to clinical criteria	TRASTUZUMAB 420 mg/vial IV Powder for Solution, Kit	04/08/2020	First Review Completed
Kanjinti KANJINTI can be used in combination with PERJETA (pertuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease	TRASTUZUMAB 420 mg/vial IV Powder for Solution, Kit	15/09/2022	First Review Completed
Kanjinti Early Breast Cancer (EBC) KANJINTI (trastuzumab) is indicated for the treatment of patients with early stage breast cancer with ECOG 0 - 1 status, whose tumours overexpress HER2, – Following surgery and after chemotherapy – Following adjuvant chemotherapy consisting of doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel – In combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. Metastatic Breast Cancer (MBC) KANJINTI is indicated for the treatment of patients with MBC whose tumours overexpress HER2. Metastatic Gastric Cancer (MGC) KANJINTI in combination with capecitabine or intravenous 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. KANJINTI should only be administered to patients with MGC whose tumours have HER2 overexpression as defined by IHC2+ confirmed by FISH+, or IHC 3+ as determined by an accurate and validated assay.	TRASTUZUMAB 150 mg intravenous, powder for solution, single dose vial	15/09/2022	First Review Completed
Kerendia As an adjunct to standard of care therapy to delay progression of kidney disease and to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, non-fatal stroke) and hospitalization for heart failure in adults with chronic kidney disease and type 2 diabetes.	FINERENONE 10 mg and 20 mg tablets	05/12/2022	Active
Kanuma For the treatment of lysosomal acid lipase (LAL) deficiency according to clinical criteria.	sebelipase alfa 2 mg/mL concentrate for solution for infusion	08/04/2021	First Review Completed
Kazano To improve glycemic control in adult patients (â‰¥ 18 years old) with type 2 diabetes mellitus	alogliptin (as alogliptin benzoate) / metformin hydrochloride 12.5 mg/ 500 mg, 12.5mg/ 850mg and 12.5mg/1000mg tablet	04/08/2015	First Review Completed
Kesimpta For the treatment of Relapsing Remitting Multiple Sclerosis according to clinical criteria.	ofatumumab 20 mg / 0.4 mL SC solution for injection, pre-filled SensoReady Pen	25/03/2022	First Review Completed
Kevzara For the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non- biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs)	sarilumab 150 mg and 200 mg solution for subcutaneous injection	31/05/2017	Active
Kevzara For the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non- biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs)	sarilumab New Format: 150 mg / 1.14 mL and 200 mg /1.14 mL prefilled pen	01/04/2019	Active
Keytruda For the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor	PEMBROLIZUMAB 50 mg/vial powder for solution for infusion	06/07/2016	First Review Completed
Keytruda For the treatment of patients with metastatic non-small cell lung carcinoma (NSCLC) whose tumours express PD-L1 (as determined by a validated test) and who have disease progression on or after platinum-containing chemotherapy	PEMBROLIZUMAB 50 mg/vial powder for solution	25/08/2016	Active
Keytruda For the treatment of patients with previously untreated metastatic non-small cell lung carcinoma whose tumours express PD-L1 (as determined by a validated test) and do not harbor a sensitized EGFR mutation or ALK translocation	PEMBROLIZUMAB 50 mg powder for solution and 100 mg/4 mL solution for infusion	06/03/2018	First Review Completed
Keytruda For the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of completing neoadjuvant or adjuvant platinum-containing chemotherapy	PEMBROLIZUMAB 50 mg powder for solution for infusion-single use vials	05/03/2018	Active
Keytruda For the treatment of cutaneous melanoma and Classical Hodgkin Lymphoma (cHL) according to clinical criteria	PEMBROLIZUMAB 50 mg powder for solution	04/08/2020	First Review Completed
Keytruda For the second treatment of advanced melanoma (re-treatment)	PEMBROLIZUMAB 50 mg solution for infusion 100 mg/4 mL vial	15/08/2019	Active
Keytruda For the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), in combination with pemetrexed and either cisplatin or carboplatin	PEMBROLIZUMAB 50 mg solution for infusion 100 mg/4 mL vial	23/10/2019	Active
Keytruda For the adjuvant treatment of melanoma (ADJ MEL)	PEMBROLIZUMAB 50 mg solution for infusion 100 mg/4mL vial	15/03/2019	Active
Keytruda Treatment of metastatic squamous NSCLC with pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel in adults with no prior systemic chemotherapy treatment for metastatic NSCLC	PEMBROLIZUMAB 50 mg solution for infusion 100 mg/4 mL vial	31/07/2019	Active
Keytruda For the first line treatment of patients with advanced or metastatic renal cell carcinoma in combination with Inlyta (axitinib) according to clinical criteria	PEMBROLIZUMAB 100 mg/4 mL vial, solution for infusion	16/03/2021	First Review Completed
Keytruda In first line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)	PEMBROLIZUMAB 25 mg/mL IV solution	15/07/2021	First Review Completed
Keytruda First line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) as monotherapy, in adult patients whose tumours have PD-L1 expression [Combined Positive Score (CPS) â‰¥ 1] as determined by a validated test. – First-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) in combination with platinum and fluorouracil (FU) chemotherapy, in adult patients	PEMBROLIZUMAB 100 mg/4mL solution for infusion vial	30/04/2021	Active
Keytruda As monotherapy for the first-line treatment of metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer according to clinical criteria	Â PEMBROLIZUMAB 100 mg/4 mL solution for infusion vial	15/02/2022	First Review Completed
Keytruda As monotherapy is indicated for the treatment of adult and pediatric patients with refractory or relapsed classical Hodgkin Lymphoma (cHL) who have failed autologous stem cell transplant (ASCT), or who are not candidates for multi-agent salvage chemotherapy and ASCT	Â PEMBROLIZUMAB 100 mg/4 mL solution for infusion vial	12/05/2022	First Review Completed
Keytruda For the adjuvant treatment of adult patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.	Â PEMBROLIZUMAB 100 mg/4 mL IV solution	23/08/2022	Active
Keytruda For the treatment of adult patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continue as monotherapy as adjuvant treatment after surgery	Â PEMBROLIZUMAB 100 mg/4 mL IV solution	08/08/2022	Active
Keytruda As monotherapy is indicated for the treatment of adult and pediatric patients with refractory or relapsed classical Hodgkin Lymphoma (cHL) who have failed autologous stem cell transplant (ASCT), or who are not candidates for multi-agent salvage chemotherapy and ASCT	PEMBROLIZUMAB 100 mg/4 mL solution for infusion vial	12/05/2022	First Review Completed
Keytruda In combination with chemotherapy for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumors express PD-L1 (Combined Positive Score [CPS] â‰¥ 10) as determined by a validated test	PEMBROLIZUMAB 100 mg/4 mL solution (IV infusion)	26/09/2022	Active
Keytruda For treatment, in combination with lenvatinib, of adult patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy, and are not candidates for curative surgery or radiation	PEMBROLIZUMAB 100 mg/4 mL vial solution (IV infusion)	30/11/2022	Active
Keytruda As monotherapy for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) for endometrial cancer that has progressed following prior therapy and who have no satisfactory alternative treatment options	PEMBROLIZUMAB 100 mg/4 mL vial solution (IV infusion)	06/12/2022	Active
Kisqali For the treatment of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER 2)-negative, unresectable locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant according to clinical criteria	ribociclib 200 mg tablet	18/11/2020	First Review Completed
Kisqali For the treatment of patients with estrogen receptor (ER)Ã¢â‚¬“positive, human epidermal growth factor receptor 2 (HER 2)-negative, unresectable locally advanced or metastatic breast cancer according to clinical criteria	ribociclib 200 mg tablet	18/11/2020	First Review Completed
Kisqali In combination with letrozole for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as an initial endocrine-based therapy	ribociclib 200 mg tablet	20/09/2019	First Review Completed
Kirsty Treatment of patients with diabetes mellitus who require insulin for the control of hyperglycemia	INSULIN ASPART 100 units/mL pre-filled pen & 100 units/mL multidose vial	31/01/2023	First Review Completed
Komboglyze Type 2 diabetes mellitus	saxagliptin HCl / metformin HCl 2.5 mg/500 mg, 2.5 mg/850 mg and 2.5 mg/1000 mg tablet	12/12/2014	First Review Completed
Kuvan BH4-responsive Phenylketonuria (PKU)	sapropterin dihydrochloride 100 mg tablet	23/04/2013	Second Review Completed
Kuvan In conjunction with a Phe-restricted diet to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4)-responsive Phenylketonuria (PKU).	sapropterin dihydrochloride 100 mg and 500 mg powder for oral solution	23/07/2020	Active
Kyleena For conception control for up to 5 years	levonorgestral 19.5 mg intrauterine system	29/05/2018	Active
Kynmobi For the acute, intermittent treatment of “OFF” episodes in patients with Parkinson’s disease (PD).	apomorphine hydrochloride 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg soluble film for sublingual administration	06/11/2020	Active
Kyprolis For use in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 prior lines of therapy	carfilzomib 60 mg lyophilized powder for solution for injection	29/05/2018	Active
Kyprolis In combination with dexamethasone alone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 lines of therapy	carfilzomib 60 mg lyophilized powder for solution for injection	22/03/2016	Active
Kyprolis In combination with lenalidomide and dexamethasone or dexamethasone alone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 lines of prior therapy	carfilzomib 10 mg/vial and 30 mg/vial powder for solution (new strengths)	29/05/2018	Active
Lancora For the treatment of stable chronic heart failure with reduced left ventricular ejection fraction (â‰¤ 35%) in adult patients with NYHA Classes II or III who are in sinus rhythm with a resting heart rate â‰¥ 77 beats per minute, to reduce the incidence of cardiovascular mortality and hospitalisations for worsening heart failure.	ivabradine HCl 5 mg and 7.5 mg FC tablet	24/10/2018	First Review Completed
Kyprolis For use in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 prior lines of therapy	carfilzomib 60 mg lyophilized powder for solution for injection	29/05/2018	Active
Kyprolis In combination with dexamethasone alone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 lines of therapy	carfilzomib 60 mg lyophilized powder for solution for injection	22/03/2016	Active
Kyprolis In combination with lenalidomide and dexamethasone or dexamethasone alone for the treatment of patients with relapsed multiple myeloma who have received 1 to 3 lines of prior therapy	carfilzomib 10 mg/vial and 30 mg/vial powder for solution (new strengths)	29/05/2018	Active
Lancora For the treatment of stable chronic heart failure with reduced left ventricular ejection fraction (â‰¤ 35%) in adult patients with NYHA Classes II or III who are in sinus rhythm with a resting heart rate â‰¥ 77 beats per minute, to reduce the incidence of cardiovascular mortality and hospitalisations for worsening heart failure.	ivabradine HCl 5 mg and 7.5 mg FC tablet	24/10/2018	First Review Completed
Lantus (Solostar Prefilled Disposable Pen) Diabetes, Type 1 & 2	insulin glargine 100 unit/mL solution 3 mL prefilled pen	26/03/2009	First Review Completed
Lapelga To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.	pegfilgrastim 6 mg, sterile solution for injection (10mg/mL)	30/08/2019	First Review Completed
Lartruvo In combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and for whom treatment with an anthracycline-containing regimen is appropriate	olaratumab 10 mg/mL, solution for infusion	11/07/2018	Active
Latuda For the acute treatment of patients with schizophrenia	lurasidone hydrochloride 40 mg, 80 mg and 120 mg tablet	27/05/2014	Second Review Completed
Latuda For the management of the manifestations of schizophrenia after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly	lurasidone hydrochloride 20 mg and 60 mg tablet	22/03/2018	First Review Completed
Livtencity For the treatment of adults with post-transplant cytomegalovirus (CMV) infection/disease who are refractory and/or resistant to one or more prior antiviral therapies.	Â MARIBAVIR Â 200 mg film-coated tablet	07/10/2022	Active
Lemtrada For the management of adult patients with relapsing remitting multiple sclerosis	alemtuzumab 12 mg/1.2 mL IV solution	26/11/2015	File Closed
Lemtrada Management of adult patients with relapsing remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies	alemtuzumab 12 mg/1.2 mL IV solution	17/02/2022	First Review Completed
Lenvima For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RR-DTC)	lenvatinib mesylate 10 mg, 14 mg, 20 mg and 24 mg capsule	31/10/2017	First Review Completed
Lenvima In combination with everolimus for the treatment of patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.	lenvatinib mesylate 10 mg, 14 mg, 20 mg and 24 mg capsule	12/12/2018	Active
Lenvima For the treatment of unresectable advanced hepatocellular carcinoma according to clinical criteria.	lenvatinib mesylate 4 mg/ dose, 8mg/ dose and 12 mg/ dose capsules	05/03/2020	First Review Completed
Lenvima In combination with pembrolizumab, for the treatment of adult patients with advanced or metastatic renal cell carcinoma (RCC) with no prior systemic therapy for metastatic RCC.	lenvatinib mesylate 20 mg daily-dose (2x10 mg), 14 mg daily-dose (1x10 mg, 1x4 mg) and 10 mg daily-dose (1x10 mg), 8 mg daily-dose (2x4 mg) capsules	26/05/2022	Active
Levemir FlexTouch The treatment of type 1 or type 2 diabetes mellitus	insulin detemir 100 unit/mL solution for injection	02/05/2014	First Review Completed
Leqvio Indicated as an adjunct to lifestyle changes, including diet, to further reduce low-density lipoprotein cholesterol (LDL-C) level in adults with the following conditions who are on maximally tolerated dose of a statin, with or without other LDL-C -lowering therapies: â€¢ Heterozygous familial hypercholesterolemia (HeFH), or â€¢ Non-familial hypercholesterolemia with atherosclerotic cardiovascular disease The effect of LEQVIO on cardiovascular morbidity and mortality has not been determined.	INCLISIRAN SODIUM 189 mg/mL (284 mg/1.5 mL) solution for subcutaneous injection	27/10/2022	Active
Libtayo For the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in patients who are not candidates for curative surgery or curative radiation according to clinical criteria.	cemiplimab 350 mg/7 mL and 250 mg/5 mL (50 mg/mL) concentrate for solution for infusion	03/02/2021	First Review Completed
Libtayo For the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 in â‰¥ 50% of tumour cells (Tumour Proportion Score [TPS] â‰¥ 50%), as determined by a validated test, with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC.	cemiplimab 350 mg/7 mL (50 mg/mL) concentrate for solution for infusion	02/03/2022	Active
Libtayo For the treatment of patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor.	cemiplimab 350 mg/7 mL (50 mg/mL) concentrate for solution for infusion	02/22/2022	Active
Lidemol For topical therapy of corticosteroid responsive acute and chronic skin eruptions	fluocinonide 0.05 % emollient cream	17/01/2012	First Review Completed
Lidex For topical therapy of corticosteroid responsive acute and chronic skin eruptions	fluocinonide 0.05 % cream	17/01/2012	First Review Completed
Lidex For topical therapy of corticosteroid responsive acute and chronic skin eruptions	fluocinonide 0.05 % ointment	17/01/2012	First Review Completed
Lidex For topical therapy of corticosteroid responsive acute and chronic skin eruptions	fluocinonide 0.05 % gel	17/01/2012	First Review Completed
Lixiana Prevention of stroke and systemic embolic events in patients with atrial fibrillation, in whom anticoagulation is appropriate	edoxaban (as edoxaban tosylate monohydrate) 15 mg, 30 mg and 60 mg FC tablet	29/05/2018	Active
Lixiana For the treatment of venous thromboembolism (VTE) (deep vein thrombosis [DVT], pulmonary embolism [PE]) and the prevention of recurrent DVT and PE	edoxaban (as edoxaban tosylate monohydrate) 15 mg, 30 mg and 60 mg FC tablet	23/04/2019	First Review Completed
Lodalis For the reduction of cholesterol blood level in patients with hypercholesterolemia (Frederickson Type IIa) as an adjunct to diet and lifestyle changes	colesevelam hydrochloride 625 mg tablet	27/05/2014	Second Review Completed
Lodalis For the reduction of cholesterol blood level in patients with hypercholesterolemia (Frederickson Type IIa) as an adjunct to diet and lifestyle changes	colesevelam hydrochloride 3.75 g/pack oral powder for suspension	29/02/2016	First Review Completed
Lokelma For the treatment of hyperkalemia in adult patients.	sodium zirconium cyclosilicate 5 gram and 10 gram per sachet powder for oral suspension	04/11/2019	Active
LOLO Combination oral contraceptive	norethindrone acetate/ethinyl estradiol/ethinyl estradiol 1.0 mg/0.010 mg/0.010 mg tablet	27/11/2015	First Review Completed
Lonsurf Treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF biological agents, and, if RAS wild-type, anti-EGFR agents	trifluridine and tipiracil HCl 15 mg/6.14 mg tablets and 20 mg/8.19 mg tablets	18/09/2018	Active
Lonsurf For the treatment of metastatic gastric cancer (mGC) or adenocarcinoma of the gastroesophageal junction (GEJ) in adult patients according to clinical criteria.	trifluridine and tipiracil HCl 15 mg & 6.14 mg and 20 mg & 8.19 mg tablet	25/03/2021	First Review Completed
Lorbrena Monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on: crizotinib and at least one other ALK inhibitor, or patients who have progressed on ceritinib or alectinib.	lorlatinib 25 mg and 100 mg tablet	24/09/2019	Active
Lotemax Post-operative inflammation following cataract surgery	loteprednol etabonate 0.5% w/v ophthalmic suspension	08/02/2011	Reconsideration Completed
Lucentis Treatment of visual impairment due to diabetic macular edema (DME)	ranibizumab 10 mg/mL solution for injection	11/12/2012	First Review Completed
Lucentis For the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)	ranibizumab 10 mg/mL solution for injection	23/01/2014	First Review Completed
Lucentis Neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME), visual impairment due to macular edema secondary to RVO which includes central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO)	ranibizumab 10 mg/mL pre-filled syringe	27/11/2015	First Review Completed
Lucentis Treatment of visual impairment due to choroidal neovascularisation secondary to pathologic myopia	ranibizumab 10mg/mL IV solution	27/11/2015	First Review Completed
Lumigan RC Elevated intraocular pressure	bimatoprost 0.01% ophthalmic solution	04/10/2010	First Review Completed
Lumigan RC Elevated intraocular pressure	bimatoprost 0.01% ophthalmic solution	18/01/2012	First Review Completed
Lutathera Treatment of unresectable or metastatic, well-differentiated, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults with progressive disease.	lutetium (177 Lu) oxodotreotide 370 MBq/mL sterile solution of intravenous infusion	26/02/2019	Active
Luxiq For the relief of the inflammatory and pruritic manifestations of moderate to severe psoriasis of the scalp	betamethasonate valerate 0.12% aerosol foam	21/01/2015	Active
Luxturna For the treatment of adult and pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.	voretigene neparvovec 5 x 1012 vector genomes/mL concentrate for solution for subretinal injection	06/11/2020	Active
Lynparza For the maintenance treatment of adult patients with platinum sensitive relapsed BRCA mutated epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response to platinum based chemotherapy.	OLAPARIB 100 mg and 150 mg capsules	02/08/2018	First Review Completed
Lynparza For the maintenance treatment of BRCA-mutated, high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients according to clinical criteria.	OLAPARIB 100 mg and 150 mg tablets	23/12/2020	First Review Completed
Lynparza As monotherapy for the treatment of adult patients with BRCA or ATM mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with a new hormonal agent.	OLAPARIB 100 mg and 150 mg tablets	15/03/2021	Active
Lynparza As monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.	OLAPARIB 50 mg capsule	29/08/2018	First Review Completed
Lynparza For the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of a germline BRCA mutation before Lynparza treatment is initiated	OLAPARIB 100 mg and 150 mg tablet	12/01/2023	Active
Lysodren For the treatment of inoperable adrenal cortical carcinoma of both functional and non-functional type.	mitotane 500 mg tablet	30/11/2021	First Review Completed
M-Eslon IR For the management of pain severe enough to require daily, continuous, long-term opioid treatment, and that is opioid-responsive; and for which alternative options are inadequate	morphine sulfate 5 mg, 10 mg, 20 mg and 30 mg extended-release capsules	01/03/2018	Active
MabCampath Treatment of B-Cell Chronic Lymphocytic Leukemia after failure of fludarabine	alemtuzumab 30 mg/mL vial	29/03/2011	Withdrawn
Mavenclad As monotherapy for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical exacerbations and delay the progression of disability. Mavenclad is generally recommended in MS patients who have had an inadequate response to, or are unable to tolerate, one or more therapies for MS	cladribine 10 mg tablet	27/02/2018	Active
Maviret Treatment of Genotype 1-6 Chronic Hepatitis C Infection	glecaprevir/pibrentasvir 100 mg/40 mg tablet	31/07/2020	First Review Completed
Mar-Trientine For the treatment of WilsonÃ¢â‚¬â„¢s Disease according to clinical criteria.	TRIENTINE HYDROCHLORIDE 250 mg capsule	25/03/2022	First Review Completed
Mayzent For the treatment of secondary progressive multiple sclerosis according to clinical criteria.	siponimod 0.25 mg and 2 mg tablet	25/03/2022	First Review Completed
MDK-Nitisinone For the treatment of patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.	nitisinone 2 mg, 5 mg, 10 mg and 20 mg capsules	23/05/2018	Active
MediSure Blood Glucose Test Strip To measure the concentration of glucose in the blood	glucose oxidase	27/11/2015	First Review Completed
Medisure Empower Blood Glucose Test Strips To measure the concentration of glucose in the blood	FAD-GLUCOSE DEHYDROGENASE (FAD-GDH)	23/11/2022	Active
Mekinist For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation	trametinib 0.5 mg and 2 mg tablet	21/08/2014	First Review Completed
Metadol-D For methadone maintenance treatment for addiction	methadone HCl 10 mg/mL liquid (oral concentrate)	10/12/2014	First Review Completed
Metadol-D For methadone maintenance treatment for addiction	methadone HCl 1 mg/mL oral solution	24/06/2015	Active
Methadose For substitution treatment in opioid drug dependence in adults	methadone HCl 10 mg/mL	23/06/2014	First Review Completed
Metoject Subcutaneous Psoriasis/psoriatic arthritis, rheumatoid arthritis	methotrexate (supplied as methotrexate sodium) 10 mg/0.2 mL, 12.5 mg/0.25 ml solution (subcutaneous) single-use pre-filled syringe	28/02/2020	First Review Completed
Metoject Subcutaneous Psoriasis/psoriatic arthritis, rheumatoid arthritis	methotrexate (supplied as methotrexate sodium) 7.5 mg/0.15 mL, 17.5 mg/0.35 mL, 20 mg/0.4 mL, 22.5 mg/0.45 mL and 25 mg/0.5 mL solution (subcutaneous) single-use pre-filled syringe	05/04/2018	First Review Completed
Metoject Subcutaneous Psoriasis/psoriatic arthritis, rheumatoid arthritis	methotrexate (supplied as methotrexate sodium) 15 mg/0.3 mL solution (subcutaneous) single-use pre-filled syringe	30/04/2019	First Review Completed
Metvix Superficial basal cell carcinoma	methyl aminolevulinate 168 mg/gm topical cream	06/07/2011	First Review Completed
Mezera For the treatment of mildly active ulcerative colitis of the sigmoid colon and rectum.	MESALAZINE 1 g/ACT rectal foam	16/11/2018	Active
Mezera For the treatment of acute mild to moderate ulcerative proctitis.	MESALAZINE 1 g rectal suppository	28/05/2019	Active
Mezera For the induction of remission in adult patients with active mild to moderate ulcerative colitis	MESALAZINE 500 mg delayed-release tablets	23/11/2022	Active
Mictoryl/ Mictoryl Pediatric For symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in patients with overactive bladder	propiverine hydrochloride 30 mg and 45 mg modified-release capsule, 5 mg tablet	29/05/2017	Active
Mifegymiso For medical termination of a developing intra-uterine pregnancy with a gestational age up to 49 days as measured from the first day of the Last Menstrual Period in a presumed 28-day cycle	mifepristone/misoprostol 200 mg/200 mcg Fixed Combination tablet-tablet packs	30/05/2017	First Review Completed
Monoferric For the treatment of patients with Iron Deficiency Anemia (IDA) who meet ALL the following criteria: – Patient has documented diagnosis of IDA confirmed by laboratory testing results (e.g. hemoglobin, ferritin); AND – Patient’s IDA has experienced a failure to respond, documented intolerance, or contraindication to an adequate trial (i.e. at least 4 weeks) of at least one oral iron therapy; AND – Patient’s IDA has experienced a failure to respond, documented intolerance, or contraindication to an adequate trial (i.e. at least 4 weeks) of at least one oral iron therapy; AND – Monoferric is administered in a setting where appropriate monitoring and management of hypersensitivity reactions can be provided to the patient.	iron isomaltoside 1000 for injection 100 mg elemental iron/mL, solution intravenous	26/02/2021	First Review Completed
Monoprost For the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension	latanoprost 50 mcg/mL solution ophthalmic	03/08/2018	Active
Monurol Sachet For the treatment of uncomplicated urinary tract infections	fosfomycin tromethamine 3 g sachet oral powder	04/08/2015	Reconsideration Completed
Movapo For the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) in patients with advanced Parkinson’s disease.	apomorphine HCl 30 mg/3 mL pre-filled pen and 20 mg/2 mL ampoule	20/09/2019	First Review Completed
Mozobil In combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma	plerixafor 24 mg/1.2 mL (20 mg/mL) subcutaneous solution	20/02/2014	First Review Completed
Multaq Atrial fibrillation	dronedarone hydrochloride 400 mg FC tablet	16/08/2011	Second Review Completed
Mvasi For the treatment of Platinum-Resistant Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PROC) according to clinical criteria.	bevacizumab 25 mg/mL (100 mg/4mL) and 25 mg/mL (400 mg/16mL) IV solution for injection	15/04/2020	First Review Completed
Mvasi In combination with paclitaxel, topotecan or pegylated liposomal doxorubicin, is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens. These patients should not have received prior VEGF-targeted therapy including MVASI.	bevacizumab 25 mg/mL IV solution for injection	16/03/2020	Active
MyGlucoHealth Test Strips To measure the concentration of glucose in the blood	glucose oxidase	28/11/2013	First Review Completed
Mylotarg For the treatment of acute myeloid leukemia according to clinical criteria.	gemtuzumab ozogamicin 4.5 mg lyophilized cake or powder for solution	15/11/2021	First Review Completed
Nypozi Hematopoietic Agent Granulocyte Colony Stimulating Factor	filgrastim 600 Âµg/mL SC, IV, solution (300 Âµg/0.5 mL prefilled syringe) and 600 Âµg/mL SC, IV, solution (480 Âµg/0.8 mL prefilled syringe)	30/06/2022	Active
Myrbetriq For the treatment of overactive bladder	mirabegron 25 mg and 50 mg ER tablet	24/06/2015	First Review Completed
Nerlynx For the early stage hormone receptor positive HER 2-overexpressed amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy.	neratinib 40 mg tablet	12/02/2020	Active
Nesina To improve glycemic control in adult patients with type 2 diabetic mellitus	alogliptin benzoate 6.25 mg, 12.5 mg and 25 mg tablet	04/08/2015	First Review Completed
Neupogen Primary prophylaxis of febrile neutropenia	filgrastim 300 mcg/mL vial and 480 mcg/1.6 mL injection	04/10/2010	First Review Completed
Neupogen Primary prophylaxis of febrile neutropenia	filgrastim 300 mcg/mL vial and 480 mcg/1.6 mL injection	24/08/2011	First Review Completed
Neupogen For primary prophylaxis of febrile neutrophilia in patients undergoing adjuvant breast cancer treatment with the TC regimen	filgrastim 300 mcg/mL vial and 480 mcg/1.6 mL injection	31/07/2013	First Review Completed
Neupogen Granulocyte colony stimulating factor	filgrastim 300 mcg (0.5 mL of 600 mcg/mL solution) & 480mcg (0.8 mL of 600 mcg/mL solution) pre-filled syringe	23/08/2017	First Review Completed
Neupro The treatment of the signs and symptoms of idiopathic Parkinson’s disease	rotigotine 2 mg/24hr, 4 mg/24hr, 6 mg/24hr and 8 mg/24hr transdermal patch	24/06/2015	First Review Completed
Neupro As adjunctive therapy to levodopa for the treatment of patients with advanced stage Parkinson’s disease	rotigotine 2 mg/24h, 4 mg/24h, 6 mg/24h, 8 mg/24h transdermal system patch	31/10/2017	First Review Completed
Nexavar Metastatic renal cell carcinoma	sorafenib tosylate 200 mg tablet	04/10/2010	First Review Completed
Nexavar Treatment of patients with locally advanced or metastatic, progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine	sorafenib 200 mg tablet	10/12/2015	First Review Completed
Nexplanon Prevention of pregnancy for up to 3 years.	ETONOGESTREL 68 mg/implant, SC implant	17/12/2021	First Review Completed
Nimotop Subarachnoid hemorrhage (SAH)	nimodipine 30 mg tablet	19/10/2011	First Review Completed
Ninlaro For the treatment of adult patients with multiple myeloma who have received at least one prior therapy and have high risk cytogenetics or have received at least two prior therapies	ixazomib citrate 2.3 mg, 3 mg and 4 mg capsule	26/09/2017	Active
Ninlaro In combination with lenalidomide and dexamethasone (Ld) is indicated for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.	ixazomib citrate 2.3 mg, 3 mg, and 4 mg capsules	23/04/2019	Active
NITISINONE TABLETS For the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.	nitisinone 2 mg, 5 mg, and 10 mg tablets	24/09/2018	Active
Nitoman Hyperkinetic movement disorders	tetrabenazine 25 mg tablet	04/10/2010	First Review Completed
Nivestym Cancer Patients Receiving Myelosuppressive Chemotherapy; Patients with Acute Myeloid Leukemia; Cancer Patients Receiving Myeloablative Chemotherapy Followed by Bone Marrow Transplantation; Cancer Patients Undergoing Peripheral Blood Progenitor Cell (PBPC) Collection and Therapy; Patients with Severe Chronic Neutropenia (SCN); Patients with HIV Infection.	filgrastim 300 mcg/0.5 mL prefilled syringe, 480 mcg/0.8 mL prefilled syringe, 300 mcg/mL single-dose vial, 480 mcg/1.6mL single-dose vial.	31/07/2020	First Review Completed
Norditropin NordiFlex For endogenous growth hormone deficiency	SOMATROPIN 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL subcutaneous solution	04/08/2015	First Review Completed
Norditropin SimpleXx Growth disturbance in children born small for gestational age	SOMATROPIN 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL solution	04/08/2015	First Review Completed
Norditropin SimpleXx Growth failure in children due to growth hormone deficiency	SOMATROPIN 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL solution	04/08/2015	First Review Completed
Â Norditropin FlexPro Â For endogenous growth hormone deficiency	SOMATROPIN 5 mg/1.5 mL, 10 mg/1.5 mL & 15 mg/1.5 mL solution (SC injection)	16/09/2022	Active
Noromby The prophylaxis of thromboembolic disorders (deep vein thrombosis) in patients undergoing: - orthopedic surgery of the hip or knee. In addition, NOROMBY is indicated in hospital or after hospital discharge for long-term prevention of venous thromboembolic diseases following hip replacement surgery. - high risk abdominal, gynecological, or urological surgeries; - colorectal surgery. – The prophylaxis of deep vein thrombosis (DVT) in medical patients who are at moderate risk of DVT and who are bedridden due to moderate to severe acute cardiac insufficiency (NYHA Class III or IV heart failure), acute respiratory failure revealing or complicating chronic respiratory insufficiency not requiring ventilatory support and acute respiratory infections (excluding septic shock), who require short-term prophylaxis of deep vein thrombosis. – The prevention of thrombus formation in the extra-corporeal circulation during hemodialysis. – The treatment of deep vein thrombosis, with or without pulmonary embolism. – The treatment of unstable angina or non-Q-wave myocardial infarction, concurrently with ASA. – Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).	enoxaparin sodium 20 mg/0.2 mL prefilled syringe	30/06/2021	First Review Completed
Noromby AND Noromby HP The prophylaxis of thromboembolic disorders (deep vein thrombosis) in patients undergoing: - orthopedic surgery of the hip or knee. In addition, NOROMBY is indicated in hospital or after hospital discharge for long-term prevention of venous thromboembolic diseases following hip replacement surgery. - high risk abdominal, gynecological, or urological surgeries; - colorectal surgery. – The prophylaxis of deep vein thrombosis (DVT) in medical patients who are at moderate risk of DVT and who are bedridden due to moderate to severe acute cardiac insufficiency (NYHA Class III or IV heart failure), acute respiratory failure revealing or complicating chronic respiratory insufficiency not requiring ventilatory support and acute respiratory infections (excluding septic shock), who require short-term prophylaxis of deep vein thrombosis. – The prevention of thrombus formation in the extra-corporeal circulation during hemodialysis. – The treatment of deep vein thrombosis, with or without pulmonary embolism. – The treatment of unstable angina or non-Q-wave myocardial infarction, concurrently with ASA. – Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).	enoxaparin sodium 30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/mL AND 120 mg/0.8 mL, 150 mg/mL pre-filled syringes	30/06/2021	First Review Completed
Norvir For the treatment of HIV infection	ritonavir 100 mg FC tablet	21/02/2012	First Review Completed
NovoRapid FlexTouch Treatment of patients with diabetes mellitus requiring insulin for the control of hyperglycemia	insulin aspart 100 U/mL prefilled disposable pen	23/04/2013	First Review Completed
Nplate Chronic immune thrombocytopenia purpura	romiplostim 250 mcg/0.5 mL and 500 mcg/mL powder for injection	16/06/2011	Second Review Completed
Nubeqa For the treatment of high risk non-metastatic castration resistant prostate cancer (nmCRPC) according to clinical criteria	DAROLUTAMIDE 300 mg tablet	08/06/2021	First Review Completed
Nubeqa For the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel	DAROLUTAMIDE 300 mg tablet	06/12/2022	Active
Nucala For add on maintenance treatment of adult patients with severe eosinophilic asthma who are inadequately controlled with high-dose inhaled corticosteroids and an additional asthma controller(s (e.g. LABA) and have high blood eosinophil count of â‰¥ to 150 cells/uL at initiation of treatment with Nucala or â‰¥ 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 â‰¥ 150 cells/ÂµL (0.15 GI/L) at initiation of treatment with NUCALA OR â‰¥ 300 cells/ÂµL (0.3 GI/L) in the past 12 months.	mepolizumab 100 mg / mL powder for solution (subcutaneous)	13/02/2020	Active
Nucala For add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by intranasal corticosteroids alone.	mepolizumab 100 mg/mL, reconstituted (144 mg/vial) lyophilized powder for solution (SC), 100 mg/mL (100 mg/ autoinjector) autoinjector (SC) & 100 mg/mL (100 mg/ syringe) pre-filled syringe (SC)	19/08/2022	Active
Nucynta For use in patients with pain severe enough to require daily, continuous, long-term opioid treatment, and that is opioid responsive and for which alternative treatment options are adequate	tapentadol 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg extended-release tablets	30/01/2019	Active
Nucynta CR For the management of moderate to moderately severe pain in adults	tapentadol 50 mg, 100 mg, 150 mg, 200 mg and 250 mg CR tablet	29/03/2012	First Review Completed
Nutropin AQ Nuspin The treatment of children who have growth failure. Treatment of short stature associated with Turner syndrome	somatropin 5 mg/2 mL/20 mg/2 mL subcutaneous solution for injection	27/11/2015	First Review Completed
Nutropin AQ NuSpin 10 Treatment of growth hormone deficiency in adults and growth failure in children	somatropin 10 mg/2 mL disposable injection pen	27/05/2014	First Review Completed
NYDA Treatment of scalp hair in case of infestation with head lice	dimeticone 50 %w/w topical solution	28/11/2013	First Review Completed
Nyvepria To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.	PEGFILGRASTIM 10 mg/mL SC solution	31/08/2021	First Review Completed
Ocaliva For the treatment of primary biliary cholangitis1 (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA	obeticholic acid 5 mg & 10 mg oral tablets	24/10/2018	First Review Completed
Ocrevus As a monotherapy for the treatment of relapsing-remitting multiple sclerosis	ocrelizumab 30 mg/mL concentrate for infusion	11/07/2018	Active
Ocrevus As monotherapy for the treatment of adult patients with primary progressive multiple sclerosis (PPMS) to delay disease progression and reduce deterioration in walking speed.	ocrelizumab 30 mg/mL concentrate for infusion (300 mg/10 mL vial)	31/10/2019	First Review Completed
Odefsey As a complete regimen for the treatment of treatment-naÃ¯ve 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 â‰¤ 100,000 copies/mL.	emtricitabine/rilpivirine/tenofovir alafenamide 200 mg/25 mg/ 25 mg tablet	29/08/2018	First Review Completed
Odefsey As a complete regimen for the treatment of treatment-naÃ¯ve 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 â‰¤ 100,000 copies/mL.	emtricitabine/rilpivirine/tenofovir alafenamide 200 mg/25 mg/ 25 mg tablet	29/08/2018	First Review Completed
Odomzo For the treatment of adult patients with histologically confirmed locally advanced basal cell carcinoma (laBCC) that is not amenable to radiation therapy or curative surgery.	sonidegib 200 mg capsule	17/08/2020	Active
Ofev Treatment of Idiopathic Pulmonary Fibrosis (IPF)	nintedanib esilate 100 mg and 150 mg capsule	15/09/2016	First Review Completed
Ofev For the treatment of chronic fibrosing interstitial lung disease according to clinical criteria.	nintedanib esilate 100 mg and 150 mg capsules	29/04/2022	First Review Completed
Ogivri For the treatment of breast and gastric cancers, according to clinical criteria.	Â TRASTUZUMAB 150 mg and 440 mg lyophilized powder for intravenous infusion	15/11/2019	First Review Completed
Ogivri OGIVRI can be used in combination with pertuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease	TRASTUZUMAB 150 mg/vial & 440 mg/vial IV, powder for solution	15/09/2022	First Review Completed
Oxlumo For the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients	LUMASIRAN 94.5 mg/0.5 mL SC solution	27/09/2022	Active
Ngenla For the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency).	SOMATROGON 24 mg/1.2 mL (20 mg/mL) and 60 mg/1.2 mL (50 mg/mL) SC injection, single-use prefilled pen	25/03/2022	Active
Olmetec Mild to moderate essential hypertension	olmesartan medoxomil 20 mg and 40 mg tablet	29/04/2010	First Review Completed
Olmetec Plus Hypertension	olmesartan medoxomil/hydrochlorothiazide 20 mg/12.5 mg, 40 mg/12.5 mg and 40 mg/25 mg tablet	29/04/2010	First Review Completed
Olumiant In combination with methotrexate (MTX) is indicated for reducing signs and symptoms of moderate to severe rheumatoid arthritis (RA).	baricitinib 2 mg tablet	31/08/2021	First Review Completed
Palynziq To reduce blood phenylalanine concentrations in patients with phenylketonuria aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/L) despite dietary management	PEGVALIASE 2.5 mg / 0.5 mL, 10 mg / 0.5 mL and 20 mg / mL SC Solution	08/07/2022	Active
Padcev For the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed deathligand 1 (PD-L1) inhibitor therapy.	ENFORTUMAB VEDOTIN 20 mg IV, powder for solution	02/12/2021	Active
Omnaris Allergic Rhinitis (seasonal and perennial)	ciclesonide 50 mcg nasal spray	25/09/2009	First Review Completed
Omnitrope Growth hormone deficiency in children and adults	somatropin 5.8 mg/vial solution	17/11/2010	First Review Completed
Omnitrope Growth hormone deficiency in children and adults	somatropin 15 mg/1.5 mL solution for injection	02/03/2018	Active
Onbrez Breezhaler For treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)	indacaterol maleate 75 mcg inhalation powder hard capsules	23/04/2013	First Review Completed
OneTouch Verio Glucose Test Strips To measure the concentration of glucose in the blood	GDH-FAD Glucose Dehydrogenase	25/11/2013	First Review Completed
Onglyza Diabetes, Type 2	saxagliptin 5 mg tablet	21/02/2012	Reconsideration Completed
Onglyza Diabetes, Type 2	saxagliptin 2.5 mg tablet	02/01/2013	First Review Completed
Onivyde Treatment of patients metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have disease progression following gemcitabine-based therapy	irinotecan hydrochloride trihydrate 4.3 mg/mL suspension for injection	28/05/2018	Active
Onpattro For the treatment of polyneuropathy in patients with hereditary transthyretin mediated amyloidosis (hATTR) according to clinical criteria.	patisiran 2 mg/1 mL solution for infusion	08/04/2021	First Review Completed
Onsolis For the management of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving, and who are intolerant to, opioid therapy for their persistent baseline cancer pain	fentanyl citrate 200 mcg, 400 mcg, 600 mcg, 800 mcg and 1200 mcg buccal soluble film	30/05/2012	First Review Completed
Onstryv Indicated as an add-on therapy to a regimen that includes levodopa for the treatment of the signs and symptoms of idiopathic Parkinson’s disease (PD) in patients experiencing “off” episodes while on a stable dose of levodopa.	safinamide mesylate 50 mg and 100 mg tablet	26/08/2019	Active
Ontruzant Early Breast Cancer (EBC) Metastatic Breast Cancer (MBC) Metastatic Gastric Cancer (MGC)	TRASTUZUMAB 150 mg/vial and 440 mg/vial IV, Powder for Solution	15/09/2022	First Review Completed
Opdivo For the first-line treatment of adult patients with advanced (unresectable or metastatic) melanoma	nivolumab 40 mg/4 mL and 100 mg/10 mL solution	31/03/2017	First Review Completed
Opdivo For advanced or metastatic renal cell carcinoma who have received prior anti-angiogenic treatment	nivolumab 40 mg/4 mL and 100 mg/10 mL solution	31/03/2017	First Review Completed
Opdivo For the treatment of patients with advanced non-small cell lung cancer (NSCLC) who progressed on or after chemotherapy	nivolumab 40 mg/4 mL and 100mg/10mL solution	31/03/2017	First Review Completed
Opdivo For the treatment of patients with classical Hodgkin Lymphoma (cHL) that has relapsed or progressed after autologous stem cell transplantation (ASCT) and brentuximab vedotin according to clinical criteria.	nivolumab 40 mg/4 mL and 100 mg/10 mL solution	01/29/2020	First Review Completed
Opdivo For the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy.	nivolumab 40 mg/4 mL, 100 mg/10 mL single-use vials and 5 mg/mL vials	06/04/2018	First Review Completed
Opdivo OPDIVO, in combination with ipilimumab for previously untreated intermediate and poor-risk patients with advanced metastatic renal carcinoma (RCC).	nivolumab 10 mg/mL Intravenous Infusion	15/05/2019	First Review Completed
Opdivo For the treatment of adult patients with advanced (not amenable to curative therapy or local therapeutic measures) or metastatic HCC that are intolerant to or have progressed on sorafenib therapy.	nivolumab 40 mg/4mL & 100 mg/10mL IV solution	16/11/2018	Active
Opdivo Adjuvant treatment for completely resected Stage 3 and 4 melanoma.	nivolumab 40 mg/4 mL and 100 mg/10 mL solution	01/04/2019	Active
Yervoy and Opdivo OPDIVO (nivolumab) in combination with YERVOY (ipilimumab) and 2 cycles of chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no known EGFR or ALK genomic tumor aberrations.	ipilimumab and nivolumab 5 mg/mL IV solution, 40 mg/ 4mL solution and 100 mg/10mL solution	12/05/2022	First Review Completed
Opdivo and Yervoy OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.	nivolumab and ipilimumab 40 mg/4 mL (10 mg/mL), 100 mg/10 mL (10 mg/mL) AND 5 mg/mL (50 mg/10 mL), 5 mg/mL (200 mg/40 mL) IV solution	12/05/2022	First Review Completed
Opdivo & Yervoy Opdivo in combination with Yervoy for the treatment of unresectable or metastatic melanoma in previously untreated adults, regardless of BRAF status	nivolumab & ipilimumab 40 mg/4 mL, 100 mg/10 mL single-use vials and 5 mg/mL vials	23/04/2019	First Review Completed
Opsumit For the treatment of patients with pulmonary arterial hypertension according to clinical criteria	macitentan 10 mg tablet	20/04/2021	First Review Completed
Oralair For the treatment of symptoms of moderate to severe seasonal grass pollen allergic rhinitis	grass pollen allergen extract 100 IR and 300 IR sublingual tablet	25/03/2014	First Review Completed
Orencia Juvenile idiopathic arthritis and juvenile rheumatoid arthritis	abatacept 250 mg/15 mLvial powder for injection	11/05/2011	First Review Completed
Orencia For adult patients with severe active rheumatoid arthritis who may and who have severe active rheumatoid arthritis despite the optimal use of various disease modifying anti-rheumatic drugs (DMARDs)	abatacept 125 mg / mL pre-filled syringes for subcutaneous injection	16/01/2014	First Review Completed
Orfadin For the treatment of patients with hereditary tyrosinemia type I (HT-1) in combination with dietary restriction of tyrosine and phenylalanine	nitisinone 2 mg, 5 mg, 10 mg and 20 mg capsules	29/11/2018	Active
Orfadin Treatment of adult and pediatric patients with confirmed diagnosis of hereditary tyrosinemia type I (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.	nitisinone 4 mg/mL oral suspension	07/09/2018	Active
Orkambi For the treatment of a subpopulation of patients with cystic fibrosis (CF): those aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene	lumacaftor & ivacaftor 200 mg & 125 mg tablet	25/06/2021	First Review Completed
Orkambi For the treatment of cystic fibrosis (CF) in patients 6 years of age and older who are homozygous for F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.	lumacaftor & ivacaftor 100 mg and 125 mg tablet	25/06/2021	First Review Completed
Osnuvo – For the treatment of postmenopausal women with severe osteoporosis who are at high risk of fracture or who have failed or are intolerant to previous osteoporosis therapy. – To increase bone mass in men with primary or hypogonadal severe osteoporosis who have failed or are intolerant to previous osteoporosis therapy. The effects of teriparatide on risk for fracture in men have not been demonstrated. – For the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men and women who are at increased risk for fracture.	teriparatide 250 mcg/mL, sterile solution for subcutaneous injection	29/09/2022	First Review Completed
Otezla For the treatment of adult patients with moderate to severe psoriasis who are candidates for phototherapy or systemic therapy	apremilast 10 mg, 20 mg and 30 mg tablet	09/02/2016	First Review Completed
Otezla For use alone or in combination with methotrexate, for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response, intolerance, or contraindication to a prior disease-modifying anti-rheumatic drug (DMARD)	apremilast 10 mg, 20 mg, 30 mg (tablet (starter pack kit) and 30 mg tablet	31/03/2016	Active
OxyContin Opioid Analgesic	oxycodone hydrochloride 15 mg, 30 mg and 60 mg tablet	05/05/2010	First Review Completed
OxyNEO For the relief of moderate to severe pain requiring the continues use of an opioid analgesic preparation	oxycodone hydrochloride 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg tablet	21/02/2012	First Review Completed
Ozanex For the treatment of impetigo in patients 2 months of age and older.	ozenoxacin 1% w/w topical antibiotic cream	10/01/2019	Active
Ozempic reducing the signs and symptoms of moderate to severe seasonal short ragweed pollen induced allergic rhinitis	semaglutide 1.34 mg/mL subcutaneous solution (multidose prefilled pen dispenses 1mg dose), and 1.34 mg/mL subcutaneous solution (multidose prefilled pen dispenses 0.25mg or 0.5mg dose).	20/09/2019	First Review Completed
Ozurdex For the treatment of macular edema following central retinal vein occlusion (CRVO)	DEXAMETHASONE 0.7 mg intravitreal implant	16/08/2012	First Review Completed
Ozurdex For the treatment of adult patients with diabetic macular edema who are pseudophakic and have had an inadequate response to prior anti-VEGF therapy	DEXAMETHASONE 0.7 mg intravitreal implant	28/09/2022	Active
Opsynvi For the long-term treatment of pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1) to reduce morbidity in patients of WHO functional class (FC) II or III whose PAH is idiopathic, heritable or associated with connective tissue disease or congenital heart disease. OPSYNVI should be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.	macitentan and tadalafil 10 mg and 40 mg film-coated tablets	08/03/2022	Active
Osphena Osphena is indicated in postmenopausal women for the treatment of moderate to severe dyspareunia and/or vaginal dryness, symptoms of vulvar and vaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM).	OSPEMIFENE 60 mg tablet	22/02/2022	Active
Ozurdex For the treatment of adult patients with diabetic macular edema (DME) who are pseudophakic and who are: - Unsuitable for anti-VEGF therapy; OR - Have inadequate response to prior anti-VEGF therapy	dexamethasone 0.7 mg intravitreal implant	15/06/2018	Active
Oxervate The treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.	CENEGERMIN 20 mcg/mL ophthalmic solution	02/03/2022	Active
Onureg For maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation (HSCT)	AZACITIDINE 200 mg & 300 mg tablet	14/11/2022	First Review Completed
Pdp- Levetiracetam For use as adjunctive therapy in the management of patients with epilepsy who are not satisfactorily controlled by conventional therapy, and who have swallowing difficulty or cannot take a solid oral pill	LEVETIRACETAM 100 mg/mL oral solution	21/12/2022	First Review Completed
Pegasys/Pegasys RBV Treatment of adult patients with chronic Hepatitis C	peginterferon alfa-2a /peginterferon alfa-2a & ribavirin 180 mcg/0.5 mL solution; 180 mcg/0.5 mL/250 mg solution/tablet kit; 180 mcg/0.5 mL/200 mg solution/tablet kit	10/12/2015	First Review Completed
Pentasa Treatment of mild to moderate active ulcerative colitis and for long-term maintenance therapy in order to maintain remission and prevent relapse of active disease and Management of mild to moderate Crohn’s Disease and maintenance of Crohn’s Disease in remission induced by surgery or medication	mesalazine (5-aminosalicylic acid) 1g ER tablet	27/11/2015	First Review Completed
PeriOlimel 2.5% E, Olimel 5.7% E, Olimel 5.7%, Olimel 7.6% E For parenteral nutrition (PN) for adults when oral or enteral (EN) nutrition is impossible, insufficient or contraindicated.	amino acids with or without electrolytes, dextrose, lipids 2.5% w/v & 0.4% w/v, 7.5% w/v, 3% w/v 5.7% w/v & 0.7% w/v, 11% w/v, 4% w/v 5.7% w/v, 11% w/v, 4% w/v 7.6% w/v & 0.8% w/v, 7.3% w/v, 3.5% w/v, IV emulsion	07/04/2021	Active
Perjeta In combination with HERCEPTIN and chemotherapy for 18 cycles for the treatment of HER2-positive early breast cancer patients at high risk of recurrence.	pertuzumab 420 mg/14 mL vial, liquid for infusion	16/11/2018	Active
Perjeta-Herceptin Combo Pack In combination with trastuzumab and docetaxel for the treatment of patients with HER2- positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease	pertuzumab 420 mg/14 mL vial concentrate for solution for infusion	28/11/2013	First Review Completed
Perjeta-Herceptin Combo Pack In combination with HERCEPTINÂ® (trastuzumab) and chemotherapy prior to surgery for the treatment of patients with HER2+ locally advanced, inflammatory, or early stage breast cancer.	pertuzumab / trastuzumab 420 mg/14 mL / 440 mg/vial	10/12/2015	First Review Completed
Piqray In combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor-positive, HER2-negative, PIK3CA- mutated advanced or metastatic breast cancer after disease progression following an endocrine-based regimen.	ALPELISIB 150 mg, 200 mg, 50 mg + 200 mg tablets	01/12/2021	Active
Pheburane As adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase	sodium phenylbutyrate 483 mg/granules	28/05/2018	Active
Phesgo Phesgo with a taxane for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. PHESGO should be administered until disease progression or unmanageable toxicity.	pertuzumab / trastuzumab 80 mg/mL / 40 mg/mL and 60 mg/mL / 60 mg/mL SC solution	16/06/2021	Active
Picato Topical treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (AK) in adults	ingenol mebutate 0.015% and 0.05% topical gel	10/12/2015	First Review Completed
Pifeltro In combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to doravirine.	doravirine 100 mg FC tablet	31/10/2019	First Review Completed
Plan B As an emergency contraceptive that can prevent pregnancy	levonorgestrel 1.5 mg tablet	15/06/2018	First Review Completed
Plegridy Treatment of relapsing remitting multiple sclerosis (RRMS) for adult patients: To reduce the frequency of clinical exacerbations and to slow the progression of disability	peginterferon beta-1a 63 mcg, 94 mcg & 125 mcg pre-filled syringe or pen	31/03/2017	First Review Completed
Pms-Fluoxetine Antidepressant / Antiobsessional / Antibulimic	fluoxetine hydrochloride 40 mg and 60 mg capsules	26/10/2020	Active
Polivy POLIVY, in combination with bendamustine and rituximab, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who are not eligible for autologous stem cell transplant and have received at least one prior therapy	polatuzumab vedotin 20 mg per mL powder for concentrate for solution for infusion	06/05/2022	First Review Completed
Polivy POLIVY, in combination with bendamustine and rituximab, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who are not eligible for autologous stem cell transplant and have received at least one prior therapy	polatuzumab vedotin 140 mg/vial, powder for concentrate for solution for infusion	06/01/2021	First Review Completed
Poteligeo For the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or SÃƒÂ©zary syndrome (SS) after at least one prior systemic therapy.	MOGAMULIZUMAB 4 mg/mL IV, solution	20/06/2022	Active
Pemazyre For the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor 2 (FGFR2) fusion or other rearrangement.	PEMIGATINIB 4.5 mg, 9 mg, and 13.5 mg tablets	24/01/2022	Active
Pomalyst Multiple myeloma (MM) for whom both bortezomib and lenalidomide have failed and who have received at least two prior treatment regimens and have demonstrated disease progression on the last regimen.	pomalidomide 1 mg, 2 mg, 3 mg and 4 mg capsule	25/02/2015	First Review Completed
Pomalyst In combination with bortezomib and dexamethasone (PVd) for patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.	pomalidomide 1 mg, 2 mg, 3 mg and 4 mg capsule	24/09/2019	Active
Ponstan For the relief of acute pain of moderate severity in various conditions	mefenamic acid 250 mg capsule	15/06/2018	File Closed
Posanol Treatment of invasive aspergillosis	posaconazole 40 mg/mL oral suspension	23/04/2013	Reconsideration Completed
Posanol Prophylaxis of Aspergillus and Candida infections and treatment of invasive aspergillosis	posaconazole 100 mg DR tablet	05/05/2015	First Review Completed
Pradaxa Venous thromboembolism prevention	dabigatran etexilate mesilate 75 mg and 110 mg capsule	02/05/2013	Second Review Completed
Pradaxa Prevention of stroke and systemic embolism in patients with atrial fibrillation	dabigatran etexilate mesilate 110 mg and 150 mg capsule	23/04/2013	First Review Completed
Praluent As an adjunct to diet and MTS therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of LDL-C	alirocumab 75 mg/mL and 150 mg/mL solution for injection	21/03/2019	First Review Completed
Prevymis For the prophylaxis of cytomegalovirus (CMV) infection in adult patients who have received an allogeneic hematopoietic stem cell transplant (HSCT) according to clinical criteria.	letermovir 240 mg and 480 mg tablets, and Solution for injection, 20 mg/mL, 240 mg/vial and 480 mg/vial, intravenous	22/01/2020	First Review Completed
Prezcobix In combination with other antiretroviral agents for the treatment of HIV infection in treatment-naÃ¯ve and in treatment-experienced patients without DRV RAMS.	darunavir/ cobicistat 800 mg/150 mg tablet	06/07/2016	First Review Completed
Prezista HIV in pediatric patients	darunavir ethanolate 75 mg tablet	27/11/2015	First Review Completed
Prezista HIV in pediatric patients	darunavir ethanolate 150 mg tablet	27/11/2015	First Review Completed
Prezista HIV in previously untreated adult patients	darunavir ethanolate 400 mg tablet	27/11/2015	First Review Completed
Prezista HIV infection in previously untreated adult patients	darunavir ethanolate 600 mg tablet	27/11/2015	First Review Completed
Prezista Treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult patients, when taken in combination with low-dose ritonavir and other antiretrovirals	darunavir ethanolate 800 mg tablet	27/11/2015	First Review Completed
Pristiq Major depressive disorder	desvenlafaxine succinate 50 mg and 100 mg ER tablet	04/10/2010	Reconsideration Completed
Probuphine For the management of opioid use disorder in combination with counseling and psychosocial support in adult patients according to specific criteria	buprenorphine hydrochloride 80 mg subdermal implant	30/04/2020	First Review Completed
Procysbi For the treatment of nephropathic cystinosis	cysteamine bitartrate 25 mg and 75 mg DR capsules	13/09/2018	First Review Completed
Prolastin Congenital alpha1-antitrypsin deficiency	alpha1-proteinase inhibitor (human) 1000 mg/vial powder for solution	17/08/2011	Second Review Completed
Propylthiouracil Tablets Thyroid therapy	PROPYLTHIOURACIL 50 mg tablet	30/09/2022	Active
Prolia Postmenopausal women with osteoporosis at high risk for fracture	denosumab 60 mg/mL pre-filled syringe	21/02/2012	First Review Completed
Prolia As a treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy	denosumab 60 mg/mL subcutaneous solution	05/04/2018	First Review Completed
Pdp-Amlodipine For the treatment of mild to moderate essential hypertension and the management of chronic stable angina (effort-associated angina) in patients who remain symptomatic despite adequate doses of beta-blockers and/or organic nitrates or who cannot tolerate those agents	AMLODIPINE BESYLATE 1 mg/mL oral solution	10/01/2023	Active
Quadramet For the relief of bone pain in patients with multiple osteoblastic skeletal metastases confirmed by positive radionuclide bone scan	samarium Sm 153 lexidronam 50 ÂµCi/mL injection	21/01/2015	Reconsideration Completed
Quinsair For the management of cystic fibrosis (CF) in patients aged 18 years or older with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections	levofloxacin hemihydrate 240 mg/2.4 mL inhalation solution	20/02/2019	First Review Completed
Retevmo For the treatment of metastatic RET fusion-positive non-small celllung cancer in adult patients, RET-mutant medullary thyroid cancer in adultand pediatric patients 12 years of age and older with unresectable advancedor metastatic disease, and RET fusion-positive differentiated thyroid carcinoma in adult patients with advanced or metastatic disease (not amenable to surgery or radioactive iodine therapy) following prior treatment with sorafenib and/or lenvatinib	SELPERCATINIB 40 mg and 80 mg capsule	10/05/2022	Active
Radicava For the treatment of amyotrophic lateral sclerosis (ALS)	EDARAVONE 30 mg / 100 mL IV solution	11/05/2020	First Review Completed
Radicava For the treatment of amyotrophic lateral sclerosis (ALS)	EDARAVONE 30 mg / 100 mL IV solution	11/05/2020	First Review Completed
Radicava For the treatment of amyotrophic lateral sclerosis	EDARAVONE 105 mg/5 mL oral suspension	21/11/2022	Active
Ragwitek Reducing the signs and symptoms of moderate to severe seasonal short ragweed pollen induced allergic rhinitis	standardized allergen extract, short ragweed (ambrosia artemisiifolia) 12 Amb a 1-U	05/05/2015	First Review Completed
Ragwitek For the treatment of moderate to severe seasonal short ragweed pollen induced AR, with or without conjunctivitis in children 5 years of age or older.	Standardized Allergen Extract, Short Ragweed (Ambrosia artemisiifolia) 12 Amb a 1-U, sublingual tablet	23/12/2020	Active
Rapaflo For the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)	silodosin 4 mg and 8 mg capsule	23/04/2013	First Review Completed
Rapid Response Blood Glucose Test Strips To measure the concentration of glucose in the blood	glucose oxidase	15/06/2018	File Closed
Rapid Response Gluco-MD-Blood Glucose Test Strips To measure the concentration of glucose in the blood	glucose oxidase	15/11/2019	Active
Rasilez HCT Mild to moderate essential hypertension	aliskiren fumarate/ hydrochlorothiazide 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg and 300 mg/25 mg tablet	06/07/2011	First Review Completed
Ravicti For chronic management of adult and pediatric patients â‰¥ 2 years of age with urea cycle disorders who cannot be managed by dietary protein restriction and/or amino acid supplementation alone	glycerol phenylbutyrate 1.1 g/mL liquid	26/06/2018	First Review Completed
Rebif Multiple sclerosis (MS)	interferon beta-1a 66 mcg/1.5 mL and 132 mcg/1.5mL prefilled multidose cartridges	01/03/2010	First Review Completed
Rebif For the treatment of clinically isolated syndrome (CIS) of multiple sclerosis	interferon beta-1a 44 mcg/0.5 mL and 132 mcg/1.5 mL (44 mcg x 3) pre-filled syringe	24/06/2015	First Review Completed
Reblozyl The treatment of adult patients with transfusion-dependent anemia requiring at least two RBC units over 8 weeks resulting from very low- to intermediate risk myelodysplastic syndromes (MDS) who have ring sideroblasts and who have failed or are not suitable for erythropoietin-based therapy	luspatercept 25 mg/vial and 75 mg/vial, subcutaneous powder for solution	09/04/2021	Active
REDESCA and REDESCA HP – The prophylaxis of thromboembolic disorders (deep vein thrombosis) in patients undergoing: - orthopedic surgery of the hip or knee; In addition, REDESCA is indicated in hospital or after hospital discharge for long-term prevention of venous thromboembolic diseases following hip replacement surgery. - high risk abdominal, gynecological, or urological surgeries - colorectal surgery – The prophylaxis of deep vein thrombosis (DVT) in medical patients who are at moderate risk of DVT and who are bedridden due to moderate to severe acute cardiac insufficiency (NYHA Class III or IV heart failure), acute respiratory failure revealing or complicating chronic respiratory insufficiency not requiring ventilatory support and acute respiratory infections (excluding septic shock), who require short-term prophylaxis of deep vein thrombosis. – The prevention of thrombus formation in the extra-corporeal circulation during hemodialysis. – The treatment of deep vein thrombosis, with or without pulmonary embolism. – The treatment of unstable angina or non-Q-wave myocardial infarction, concurrently with ASA. – Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI)	enoxaparin sodium 100 mg/mL, 150 mg/mL PFS, Vial	30/04/2021	First Review Completed
Relaxa For the treatment of occasional constipation in adults	polyethylene glycol 3350 510 g powder for suspension	17/08/2012	Withdrawn
Relenza Influenza A and B infection	zanamivir 5 mg/blister powder for inhalation	01/03/2010	First Review Completed
Relistor Constipation, Opioid-Induced	methylnaltrexone bromide 20 mg/mL solution	10/07/2009	First Review Completed
Renagel For the treatment of patients with severe renal impairment when a calcium salt is clinically contraindicated or does not provide optimal control of hyperphosphatemia.	sevelamer HCl 800 mg tablet	29/02/2016	First Review Completed
Renflexis For the treatment of Rheumatoid Arthritis (Adult), Ankylosing Spondylitis, Crohn's Disease (Adult, Pediatric), Fistulising Crohn's Disease (Adult), Ulcerative Colitis (Adult, Pediatric), Psoriatic Arthritis, and Plaque Psoriasis (Adult)	infliximab 100 mg/vial powder for solution	20/09/2018	First Review Completed
Renvela For the treatment of hyperphosphatemia according to clinical criteria.	sevelamer carbonate 800 mg tablet and powder for oral suspension 0.8 g and 2.4 g sachets	07/06/2021	First Review Completed
Repatha As adjunctive therapy to lower low density lipoprotein cholesterol (LDL-C)	evolocumab 140 mg/mL (140 mg/1.0 mL) solution (subcutaneous)	15/06/2018	First Review Completed
Repatha For the treatment of patients as an adjunct to diet and maximally tolerated statin therapy in adult patients with clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of low density lipoprotein cholesterol (LDL-C).	evolocumab 140 mg/mL (140 mg/1.0 mL) solution (subcutaneous)	28/05/2018	Active
Repatha As an adjunct to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH)	evolocumab 120 mg/mL solution for subcutaneous injection	15/06/2018	First Review Completed
Resotran For the treatment of chronic idiopathic constipation in adult female patients in whom laxatives failed to provide adequate relief	prucalopride succinate 1 mg and 2 mg FC tablet	22/10/2012	First Review Completed
Restasis Treatment of moderate to moderately severe aqueous deficient dry	cyclosporine 0.05% w/v ophthalmic emulsion	27/11/2013	Reconsideration Completed
Retin-A Micro For topical application in the treatment of acne vulgaris	tretinoin 0.1 % microsphere gel and 0.04 % microsphere gel (50 g pump)	06/11/2020	Active
Revestive For the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support	teduglutide 5 mg per vial	23/01/2019	First Review Completed
Revestive For the ongoing treatment of patients between 1 and 17 years of age with Short Bowel Syndrome (SBS) who are dependent on parenteral support according to clinical criteria.	teduglutide 5 mg powder for solution for injection	06/04/2021	First Review Completed
Revlimid Multiple myeloma in patients who have received at least one prior therapy	lenalidomide 5 mg, 10 mg, 15 mg and 25 mg capsule	21/08/2009	First Review Completed
Revlimid As maintenance treatment of newly diagnosed multiple myeloma patients after stem-cell transplantation	lenalidomide 5 mg, 10 mg, 15 mg and 25 mg capsule	29/02/2016	First Review Completed
Revlimid For the treatment of newly diagnosed multiple myeloma patients who are not candidate for stem cell transplantation	lenalidomide 5 mg, 10 mg, 15 mg and 25 mg capsule	26/06/2018	First Review Completed
Revlimid For the treatment of multiple myeloma in combination with dexamethasone for patients who are not candidate for autologous stem cell transplant	lenalidomide 20 mg capsule	26/06/2018	First Review Completed
Revlimid Newly diagnosed multiple myeloma patients who are not eligible for transplant	lenalidomide 2.5 mg tablet	22/11/2018	First Review Completed
Revlimid For the treatment of multiple myeloma in transplant ineligible patients according to clinical criteria.	lenalidomide 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg capsules	16/12/2020	First Review Completed
Revolade For adult chronic immune (idiopathic) thrombocytopenic purpura	eltrombopag olamine 25 mg and 50 mg tablet	17/04/2013	Reconsideration Completed
Revolade To increase platelet counts in thrombocytopenic patients with chronic hepatitis C virus (HCV) infection to allow the initiation and maintenance of interferon-based therapy.	eltrombopag olamine 25 mg and 50 mg tablet	30/07/2015	First Review Completed
Rexulti For the treatment of schizophrenia in adults.	brexpiprazole 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg tablet	23/04/2019	First Review Completed
Riabni For the treatment of various cancer indications according to clinical criteria.	rituximab 10 mg/mL intravenous infusion	15/03/2022	First Review Completed
Rightest Blood Glucose Monitoring System GAI Test Strips To measure the concentration of glucose in the blood	glucose oxidase	30/11/2015	File Closed
Rituxan Relapsed chronic lymphocytic leukemia	rituximab 10 mg/mL injection	29/01/2015	Reconsideration Completed
Rituxan Previously untreated chronic lymphocytic leukemia	rituximab 10 mg/mL injection	02/07/2010	First Review Completed
Rituxan SC CD20 positive, diffuse large B-cell non-Hodgkin’s lymphoma; follicular non-Hodgkin’s lymphoma	rituximab 120 mg/mL (1400 mg/ 11.7 mL) solution (subcutaneous)	26/06/2018	First Review Completed
Rituxan SC CD20 positive, diffuse large B-cell non-Hodgkin’s lymphoma; follicular non-Hodgkin’s lymphoma	rituximab 120 mg/mL (1400 mg/ 11.7 mL) solution (subcutaneous)	26/06/2018	First Review Completed
Rituxan SC For the treatment of chronic lymphocytic leukemia (CLL)	rituximab 120 mg/mL solution for subcutaneous injection (1600 mg/13.4 mL) single dose vial	21/03/2019	First Review Completed
Rituxan; Rituxan SC Rituxan/Rituxan SC for the treatment with salvage chemotherapy for relapsed/refractory aggressive histology CD20+ lymphoma with intent to proceed to stem cell transplant	rituximab; rituximab SC 10 mg/mL solution for IV administration and 120 mg/mL solution SC	20/09/2019	Active
Riximyo For the treatment of Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) according to clinical criteria.	rituximab 100 mg/10 mL and 500 mg/ 50mL intravenous solution	04/08/2020	First Review Completed
Riximyo In combination with glucocorticoids for the induction of remission in adult patients with severely active Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).	RITUXIMAB 10 mg/ mL injection solution	31/08/2021	First Review Completed
Rosiver For the topical treatment of inflammatory lesions (papules and pustules) of rosacea in adults 18 years of age or older	ivermectin 1% topical cream	29/02/2016	Active
Rovamycine 250mg capsule Treatment of infections due to susceptible organism	spiramycin 750000 I.U.	26/06/2018	File Closed
Rozlytrek For the treatment of patients with ROS1-positive, locally advanced or metastatic non-small cell lung cancer.	entrectinib 100 mg and 200 mg capsules	23/12/2022	First Review Completed
Rozlytrek For the treatment of adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options.	entrectinib 100 mg and 200 mg capsules	15/03/2022	Active
Ruxience For the treatment of Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) according to clinical criteria.	rituximab 10 mg/mL intravenous solution	04/08/2020	First Review Completed
Ruzurgi For the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older.	AMIFAMPRIDINE 10 mg tablet	23/02/2021	Active
Rybelsus For the treatment of adult patients with type 2 diabetes to improve glycemic control: – in combination with metformin, and – in combination with metformin and sulfonylurea	semaglutide 3 mg, 7 mg and 14 mg tablets	01/06/2021	Active
Rinvoq The treatment of adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment (e.g., steroid or biologic) or when use of those therapies is inadvisable.	UPADACITINIB 15 mg and 30 mg oral tablet	03/03/2022	Active
Rinvoq For the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other DMARDs.	UPADACITINIB 15 mg ER tablets	25/03/2022	Active
Rinvoq For the treatment of moderately to severely active Rheumatoid Arthritis (RA)	UPADACITINIB 15 mg ER tablets	31/10/2022	First Review Completed
Rinvoq For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or a biologic agent (i.e., tumour necrosis factor-alpha [TNFÎ±] antagonists, integrin receptor antagonists or interleukin 12/23 inhibitors)	UPADACITINIB 15 mg, 30 mg and 45 mg extended-release tablets	12/12/2022	Active
Rinvoq For the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate	UPADACITINIB 15 mg ER tablets	16/11/2022	First Review Completed
Rydapt For the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 gene mutation positive in combination with standard induction and consolidation chemotherapy	midostaurin 25 mg capsule	22/11/2018	First Review Completed
Rydapt For the treatment of adult patients with aggressive systemic mastocytosis (AsM) systemic mastocystosis with associated hematological neoplasm (SM-AHN) or mast cell leukemia (MCL) known collectively as advanced systemic Mastocysistic (advSM).	midostaurin 25 mg capsule	08/10/2019	Active
Rylaze As a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 year or older who have developed hypersensitivity to E. coli-derived asparaginase	CRISANTASPASE RECOMBINANT 10 mg/0.5 mL solution (IM injection)	13/12/2022	Active
Saizen Growth hormone deficiency	somatropin 6 mg/cartridge (5.83 mg/mL), 12 mg/cartridge (8 mg/mL) and 20 mg/cartridge (8 mg/mL)	18/01/2012	First Review Completed
Samsca For the treatment of clinically important, non-hypovolemic hyponatremia	tolvaptan 15 mg, 30 mg and 60 mg tablet	28/01/2014	Second Review Completed
Sanctura XR Overactive bladder	trospium chloride 60 mg capsule	29/04/2011	First Review Completed
Saphnelo In addition to standard therapy for the treatment of adult patients with active, autoantibody positive, systemic lupus erythematosus.	ANIFROLUMAB 300 mg/2 mL solution for infusion single-use vial	06/06/2022	Active
Santyl For the debridement of dermal ulcer or severely burned areas	collagenase 250 unit/g topical ointment	19/09/2013	Reconsideration Completed
Saphris Treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder	asenapine 5 mg and 10 mg tablet	20/02/2014	Second Review Completed
Sarclisa In combination with pomalidomide and dexamethasone, for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.	isatuximab 100 mg/5 mL and 500 mg/ 25mL (20 mg/mL) IV solution for infusion	06/11/2020	Active
Simlandi Biological Response Modifier	ADALIMUMAB 40 mg / 0.4 mL & 80 mg / 0.8 mL, SC Solution	31/05/2022	First Review Completed
Semglee Type 1 or Type 2 Diabetes Mellitus (>17 years of age) For once-daily subcutaneous administration in the treatment of patients over 17 years of age with Type 1 or Type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. â€¢ Type 1 Diabetes Mellitus (>6 years of age) In the treatment of pediatric patients (Ëƒ6 years old) with Type 1 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia	INSULIN GLARGINE 100 units/mL solution for subcutaneous injection, pre-filled pen	21/12/2022	First Review Completed
Tavalisse For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to other treatments	FOSTAMATINIB 100 mg and 150 mg tablet	31/01/2022	Active
Sarclisa In combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.	ISATUXIMAB 100 mg/5 mL (20 mg/mL) and 500 mg/25 mL IV solution	02/03/2022	Active
Saxenda Saxenda as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients who have been diagnosed with: – Obesity (BMI â‰¥30 kg/m2) AND prediabetes, or – Overweight (BMI â‰¥27 kg/m2 and <30 kg/m2) with one or more weight-related comorbidity AND prediabetes.	LIRAGLUTIDE 6 mg / mL SC solution	01/06/2021	Active
Scemblix For the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase previously treated with two or more tyrosine kinase inhibitors	ASCIMINIB 20 mg and 40 mg tablet	14/09/2022	Active
Seebri Breezhaler A long-term maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema	glycopyrronium bromide 50 mcg capsule for inhalation	22/08/2013	First Review Completed
Segluromet – Added on to metformin for patients who have inadequate glycemic control on metformin and have a contraindication or intolerance to a sulfonylurea, or – To replace the individual components of ertugliflozin and metformin for those patients who are on both therapies.	ertugliflozin and metformin HCl 2.5 mg/ 500 mg, 2.5 mg/ 1000 mg, 7.5 mg/ 500 mg, and 7.5 mg/ 1000 mg tablets	02/11/2018	Active
Seroquel XR Schizophrenia	quetiapine fumarate 150 mg ER tablet	07/01/2011	First Review Completed
Signifor For the treatment of patients with Cushing’s disease	pasireotide diaspartate 0.3 mg/ mL, 0.6 mg/ mL and 0.9 mg/ mL subcutaneous solution	04/08/2015	First Review Completed
Siliq For the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy	brodalumab 210 mg/1.5 mL, sub-cutaneous injection, pre-filled syringe	23/04/2019	First Review Completed
Silkis Antipsoriatic agent	calcitriol 3 mcg/g topical ointment	26/07/2011	First Review Completed
Simbrinza Elevated Intraocular Pressure Therapy	brinzolamide & brimonidine tartrate 1.0% w/v & 0.2% w/v ophthalmic suspension	30/11/2015	First Review Completed
Simponi Rheumatoid arthritis	golimumab 50 mg/ 0.5 mL solution	07/12/2010	First Review Completed
Simponi Psoriatic arthritis	golimumab 50 mg/ 0.5 mL solution	07/01/2011	First Review Completed
Simponi Ankylosing spondylitis	golimumab 50 mg/0.5 mL solution	07/01/2011	First Review Completed
Simponi For the treatment of patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, or have medical contraindications for, conventional therapy	golimumab 50 mg/ 0.5 mL and 100 mg/ 1.0 mL pre-filled syringe and autoinjector	30/11/2015	First Review Completed
Simponi I.V. Treatment of moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)	golimumab 50 mg/4 mL solution for infusion	30/11/2015	First Review Completed
Skyrizi For the treatment of moderate to severe plaque psoriasis	RISANKIZUMAB 75 mg in 0.83 mL (90 mg/ mL) SC solution for injection	31/01/2020	First Review Completed
Skyrizi For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy	RISANKIZUMAB 150 mg/mL 1 mL single use prefilled syringe and 150 mg/mL 1mL single use prefilled pen	31/10/2022	First Review Completed
SMOFlipid For supply of energy and essential fatty acids and omega-3 fatty acids to adult patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated	soybean oil, medium chain triglycerides, olive oil and fish oil 6%/ 6%/ 5%/ 3% w/v injectable emulsion	22/03/2018	First Review Completed
Soliqua As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) alone or in combination with metformin.	Insulin glargine and Lixisenatide 100 units/mL & 33 mcg/mL solution for injection in a prefilled pen for subcutaneous injection (3mL prefilled pen)	20/12/2019	First Review Completed
Soliris Paroxysmal nocturnal hemoglobinuria (PNH)	eculizumab 10 mg/mL solution	08/09/2011	Second Review Completed
Soliris For the treatment of patients with atypical hemolytic uremic syndrome (atypical HUS) to reduce complement-mediated thrombotic microangiopathy	eculizumab 10 mg/mL solution	30/11/2015	Second Review Completed
Soliris For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. SOLIRIS is not intended for acute treatment of an NMOSD relapse	eculizumab 10 mg/ mL IV solution	19/08/2020	Active
Soliris In adult patients with generalized Myasthenia Gravis (gMG).	eculizumab 10 mg/ mL IV solution	19/08/2020	Active
Somavert For the treatment of acromegaly in patients who have had an inadequate response to surgery, and/or radiation therapy or for whom these therapies are not appropriate	pegvisomant 25 mg and 30mg powder for solution	02/03/2018	Active
Sovaldi Treatment of chronic hepatitis C virus (CHC) infection in adult patients with compensated liver disease, including cirrhosis, as follows: (1) For the treatment of genotype 1 and genotype 4 CHC infection in combination with pegylated interferon and ribavirin; (2) For the treatment of genotype 2 and genotype 3 CHC infection in combination with ribavirin	sofosbuvir 400 mg tablet	25/02/2015	First Review Completed
Spinraza For the treatment of Type 1 spinal muscular atrophy (SMA) according to clinical criteria.	nusinersen sodium 2.4 mg/mL solution for intrathecal injection	22/11/2018	First Review Completed
Spinraza Expanded Indication: To include adult type II & type III Spinal Muscular Atrophy (SMA) patients older than 18 years of age regardless of ambulatory status	nusinersen sodium 2.4 mg/mL solution for intrathecal injection	17/03/2022	Active
Spirit Blood Glucose Test Strips To measure the concentration of glucose in the blood	glucose oxidase	26/06/2018	First Review Completed
Spiriva Respimat Long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, and for the reduction of exacerbations	tiotropium bromide monohydrate 2.5 mcg per actuation, solution for inhalation	31/05/2016	First Review Completed
Spravato In combination with a SSRI or SNRI, for the treatment of major depressive disorder in adults who have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current moderate to severe depressive episode.	esketamine hydrochloride 28 mg/ ACT nasal solution	28/07/2020	Active
Sprycel For the treatment of adults with newly diagnosed chronic myeloid leukemia in chronic phase	dasatinib 100 mg tablet	27/03/2012	First Review Completed
Stalevo Parkinson’s Disease	carbidopa/ levodopa/ entacapone 75 mg and 125 mg tablet	03/11/2010	First Review Completed
Stalevo Parkinson’s Disease	carbidopa/ levodopa/ entacapone 50 mg, 100 mg and 150 mg tablet	25/02/2009	First Review Completed
Statstrip Xpress Glucose Test Strips To measure the concentration of glucose in the blood.	Enzyme, Amperometric Glucose Enzyme (Aspergillus sp., >1.0 IU)	11/10/2018	Active
Steglatro – As monotherapy for patients who have inadequate glycemic control and for whom metformin or a sulfonylurea is inappropriate due to contraindications or intolerance. – Add-on to metformin for patients who have inadequate glycemic control on metformin and have a contraindication or intolerance to a sulfonylurea.	ertugliflozin 5 mg and 15 mg tablets	01/11/2018	Active
Stelara Psoriasis	ustekinumab 45 mg/ 0.5 mL solution	20/09/2010	First Review Completed
Stelara Psoriasis	ustekinumab 90 mg/ 1mL pre-filled syringe	28/11/2013	First Review Completed
Stelara For the treatment of moderate to severe Psoriatic Arthritis	ustekinumab 45 mg/0.5 mL and 90 mg/1 mL subcutaneous solution	24/02/2015	First Review Completed
Stelara For the treatment of adult patients with moderately to severely active Crohn’s disease, who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFÎ±) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids	ustekinumab 90 mg/ mL pre-filled syringe and 130 mg/26 mL single-use vial	29/05/2017	Active
Stelara For the treatment of adult patients with moderately to severely active ulcerative colitis (UC)	ustekinumab 130 mg/26 mL, Solution for Subcutaneous Injection 90 mg/1.0 mL, Solution for Intravenous Infusion	30/07/2020	Active
Stivarga Treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy	regorafenib 40 mg tablet	02/05/2014	First Review Completed
Stivarga Treatment of adult patients with metastatic and/or unresectable gastrointestinal stromal tumors who have had disease progression on or intolerance to imatinib mesylate and sunitinib malate treatment	regorafenib 40 mg tablet	29/09/2014	First Review Completed
Stivarga For the treatment of patients with ECOG status of </=1 and with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-based chemotherapy, an oxaliplatin, irinotecan, an anti-VEGF therapy and, if KRAS wild type, an anti-EGFR therapy	regorafenib 40 mg tablet	30/11/2015	First Review Completed
Stivarga Treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib	regorafenib 40 mg tablet	20/09/2019	First Review Completed
Stramucin Topically for the treatment of secondarily infected traumatic lesions such as small lacerations, suture wounds or abrasions.	mupirocin 2% w/w cream	30/09/2020	First Review Completed
Strensiq Enzyme replacement therapy for patients with confirmed diagnosis of paediatric-onset hypophosphatasia (HPP)	asfotase alfa 40 mg/mL and 100 mg/mL solution for injection	25/06/2018	First Review Completed
Stribild As a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment-naÃ¯ve adult patients aged 18 years and older	elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate 150 mg/ 150 mg/ 200 mg/ 300 mg tablet	30/11/2015	First Review Completed
Sublinox Short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings and/or early morning awakenings	zolpidem tartrate 5 mg and 10 mg orally disintegrating tablet	27/05/2014	Reconsideration Completed
Sublocade For the management of moderate to severe opioid use disorder as a part of a complete treatment plan that includes counselling and psychosocial support in adult patients according to specific criteria.	buprenorphine 100 mg/ 0.5mL and 300 mg/ 1.5mL subcutaneous, solution ER	30/04/2020	First Review Completed
Suboxone For substitution treatment in adults with problematic opioid drug dependence	buprenorphine/naloxone 12 mg/3 mg and 16 mg/4 mg sublingual tablets	06/03/2018	Active
Suboxone For substitution treatment in adults with problematic opioid drug dependence.	buprenorphine/naloxone 2 mg/ 0.5 mg, 8 mg/ 2 mg and 12 mg/ 3 mg soluble film	31/08/2020	Active
Sunvepra Treatment of chronic Hepatitis C infections in combination with other drugs	asunaprevir 100 mg capsule	26/06/2018	File Closed
Suretest Blood Glucose Test strips To measure the concentration of glucose in the blood	glucose oxidase	05/05/2015	First Review Completed
Sutent For the treatment of patients with unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumor (pNET)	sunitinib malate 12.5 mg, 25 mg and 50 mg capsule	15/10/2013	First Review Completed
Sylvant For the treatment of patients with Multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV)-negative and human herpes virus-8 (HHV-8)-negative.	siltuximab 100 mg/ vial, 400 mg/ vial lyophilized powder for injection	28/03/2017	First Review Completed
Symtuza For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years or older with body weight at least 40 kg) and with no known mutations associated with resistance to the individual components of SYMTUZA.	darunavir/ cobicistat/ emtricitabine & tenofovir alafenamide 800 mg/ 150 mg/ 200 mg/ 10 mg film-coated tablets	20/07/2018	Active
Synjardy As an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus inadequately controlled on: – metformin; – sulfonylurea in combination with metformin; – pioglitazone in combination with metformin; – insulin in combination with metformin; OR in patients already being treated and achieving glycemic control with: – metformin and empagliflozin as separate tablets; – sulfonylurea in combination with metformin and empagliflozin as separate tablets; – pioglitazone in combination with metformin and empagliflozin as separate tablets; – insulin in combination with metformin and empagliflozin as separate tablets	empagliflozin & metformin HCl 5 mg & 500 mg, 5 mg & 850 mg, 5 mg & 1000 mg, 12.5 mg & 500 mg, 12.5 mg & 850 mg and 12.5 mg & 1000 mg FC tablet	24/10/2018	First Review Completed
Tafinlar For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation	dabrafenib mesylate 50 mg and 75 mg capsule	21/08/2014	First Review Completed
Tafinlar In combination with Mekinist (trametinib), for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of lymph node(s), following complete resection.	dabrafenib mesylate 50 mg and 75 mg capsule	07/01/2020	First Review Completed
Tafinlar & Mekinist For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation	dabrafenib mesylate & trametinib dimethyl sulfoxide 50 mg, 75 mg capsule & 0.5 mg, 2 mg tablet	26/06/2018	First Review Completed
Tafinlar & Mekinist In combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600 mutation whose disease has progressed following systemic therapy	dabrafenib mesylate & trametinib dimethyl sulfoxide 50 mg, 75 mg capsule & 0.5 mg, 2 mg tablet	26/06/2018	First Review Completed
Tafinlar & Mekinist TAFINLAR and MEKINIST in combination for the treatment of patients with metastatic NSCLC with a BRAF V600 mutation and who have not received any prior anti-cancer therapy for metastatic disease.	dabrafenib mesylate & trametinib dimethyl sulfoxide 50 mg, 75 mg capsule & 0.5 mg, 2 mg tablet	19/03/2021	Active
Tagrisso Treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer who have progressed on or after EGFR tyrosine kinase inhibitor therapy	OSIMERTINIB 40 mg and 80 mg tablet	22/11/2018	First Review Completed
Tagrisso For the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations).	OSIMERTINIB 40 mg and 80 mg tablet	10/01/2020	First Review Completed
Tagrisso As adjuvant therapy after tumour resection in patients with stage IB-IIIAi non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations	OSIMERTINIB 40 mg and 80 mg tablet	15/11/2022	First Review Completed
Takhzyro For the routine prevention of attacks of hereditary angioedema (HAE) according to clinical criteria.	lanadelumab 150 mg/mL solution in a single-use vial subcutaneous injection	02/02/2021	First Review Completed
Takhzyro For the routine prevention of attacks of hereditary angioedema (HAE) according to clinical criteria.	lanadelumab 300 mg /2 mL solution for SC injection	14/01/2022	First Review Completed
Taltz For the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy	ixekizumab 80 mg/mL solution (subcutaneous) pre-filled auto-injector and 80 mg/mL solution (subcutaneous) pre-filled syringe	22/03/2018	First Review Completed
Taltz For the treatment of adult patients with active psoriatic arthritis who have responded inadequately to, or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDS).	ixekizumab 80 mg/ mL pre-filled autoinjector and syringe	21/03/2019	First Review Completed
Taltz For the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to, or are intolerant to conventional therapy.	ixekizumab 80 mg/ mL prefilled autoinjector and 80 mg/ mL prefilled syringe	21/02/2020	Active
Tamiflu Antiviral agent	oseltamivir phosphate 30 mg and 45 mg capsule	21/03/2011	First Review Completed
Tamiflu Antiviral agent	oseltamivir phosphate 6 mg/mL powder for suspension	25/09/2012	File Closed
Tapazole For the treatment of hyperthyroidism	methimazole 5 mg tablet	30/07/2015	First Review Completed
Tezspire As an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma	TEZEPELUMAB 110 mg/mL SC solution	06/09/2022	Active
Tepmetko For the treatment of adult patients with locally advanced unresectable or metastatic non small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET)tyrosine kinase receptor exon 14 skipping alterations.	TEPOTINIB 225 mg oral tablet	31/01/2022	Active
Tarceva Treatment of non-small cell lung cancer in the first-line maintenance setting	erlotinib 25 mg, 100 mg and 150 mg tablet	20/10/2011	First Review Completed
Targin Relief of pain and opioid induced constipation	oxycodone hydrochloride/naloxone hydrochloride 10/5 mg, 20/10 mg and 40/20 mg CR tablet	22/10/2012	Second Review Completed
Tasigna For the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase	nilotinib 200 mg capsule	26/07/2011	Reconsideration Completed
Tasigna For the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase	nilotinib 150 mg capsule	17/04/2012	First Review Completed
Tykess Blood Glucose Test Strips To measure the concentration of glucose in the blood.	GLUCOSE OXIDASE (A. Niger) 10% Test Strip	14/03/2022	Active
Taxotere Early stage breast cancer	docetaxel 20 mg/ 0.5 mL and 80 mg/ 2.0 mL solution	04/10/2010	File Closed
Tecentriq In combination with nab-paclitaxel for the treatment of adult patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 and who have not received prior chemotherapy for metastatic disease. Maintenance TECENTRIQ + nab-paclitaxel should be continued until disease progression or unacceptable toxicity.	atezolizumab 1200 mg/ 12 mL vial	28/10/2019	Active
Tecentriq For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or after systemic chemotherapy, until loss of clinical benefit	atezolizumab 1200 mg/ 12 mL vial	20/12/2019	First Review Completed
Tecentriq For the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC) in combination with a platinum-based chemotherapy and etoposide. Maintenance Tecentriq should be continued until loss of clinical benefit or unacceptable toxicity.	atezolizumab 1200 mg/ 12 mL vial	28/08/2019	Active
Tecentriq and Avastin In combination with AVASTIN (bevacizumab), for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who require systemic therapy.	atezolizumab 1200 mg/20 mL (60mg/mL) and 25 mg/mL (100 mg/4mL & 400 mg/16 mL) concentrate for solution for infusion	15/03/2022	First Review Completed
Tecentriq Monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after cytotoxic chemotherapy until unacceptable toxicity or confirmed disease progression.	atezolizumab 840 mg /14 mL Intravenous solution, concentrate, single use vials	12/01/2022	First Review Completed
Tecentriq First-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC) in combination with carboplatin and etoposide.	atezolizumab 1200 mg/20 mL (60 mg/mL) solution	02/03/2022	Active
Tecentriq Tecentriq in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive stage small cell lung cancer.	atezolizumab 1200 mg/ 12 mL vial	04/11/2019	Active
Tecentriq and Avastin In combination with AVASTIN (bevacizumab), for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who require systemic therapy.	atezolizumab 1200 mg/20 mL (60mg/mL) and 25 mg/mL (100 mg/4mL & 400 mg/16 mL) concentrate for solution for infusion	18/12/2020	Active
Tecfidera As monotherapy for the treatment of relapsing remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of disability	dimethyl fumarate 120 mg DR capsule	27/05/2014	First Review Completed
Tecfidera As monotherapy for the treatment of relapsing remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the progression of disability	dimethyl fumarate 240 mg DR capsule	12/12/2014	First Review Completed
Technivie Treatment of adults with genotype 4 chronic hepatitis C virus infection without cirrhosis who are either treatment naÃ¯ve or previously treated with peginterferon and ribavirin.	ombitasvir/ paritaprevir/ ritonavir 12.5 mg/ 75 mg/ 50 mg tablet	31/03/2016	Active
Tecta Conditions where a reduction of gastric acid secretion is required	pantoprazole magnesium 40 mg EC tablet	30/06/2010	First Review Completed
Tegsedi For the treatment of polyneuropathy in patients with hereditary transthyretin-mediated amyloidosis (hATTR) according to clinical criteria.	inotersen 284 mg inotersen / 1.5 mL per syringe [189 mg inotersen / mL (as inotersen sodium)] solution for injection	20/07/2020	First Review Completed
Trodelvy For adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received at least two therapies, including at least one prior therapy for unresectable locally advanced or metastatic disease.	SACITUZUMAB GOVITECAN 180 mg/vial IV, powder for solution	01/11/2021	Active
TBC For the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have an inadequate response to, or are intolerant of, a C5 inhibitor	PEGCETACOPLAN 54 mg/mL solution (SC infusion)	04/01/2023	Active
Ultomiris For the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)	RAVULIZUMAB 10 mg/mL IV solution	23/12/2021	Active
Ultomiris For the treatment of adults and pediatric patients with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy	RAVULIZUMAB 10 mg/mL IV solution	06/12/2022	Active
Ultomiris For the treatment of adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized Myasthenia Gravis (gMG)	RAVULIZUMAB 10 mg/mL solution (IV infusion)	06/01/2023	Active
Vabysmo For the treatment of diabetic macular edema (DME)	FARICIMAB 6 mg/0.05 mL solution for intravitreal injection	04/08/2022	Active
Vabysmo For the treatment of neovascular (wet) age-related macular degeneration (AMD)	FARICIMAB 6 mg/0.05 mL solution for intravitreal injection	02/08/2022	Active
Vyepti For the prevention of migraine in adults who have at least 4 migraine days per month	EPTINEZUMAB 100 mg/mL IV solution	15/09/2022	Active
Vegzelma Metastatic Colorectal Cancer (mCRC) Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer Malignant Glioma (WHO Grade IV) - Glioblastoma	BEVACIZUMAB 100 mg/4 mL & 400 mg/16 mL vial solution for injection	16/01/2023	Active
Verquvo To reduce the risk of cardiovascular death and heart failure (HF) hospitalization, in adults with symptomatic chronic HF and ejection fraction less than 45% who are stabilized after a recent worsening HF event	VERICIGUAT 2.5 mg, 5 mg and 10 mg tablet	03/02/2023	Active
Temodal Newly diagnosed glioblastoma multiforme. Recurrent or progressive glioblastoma multiforme or anaplastic astrocytoma	temozolomide 140 mg and 180 mg capsule	08/09/2011	First Review Completed
Thalomid For treatment of previously untreated multiple myeloma in patients who are 65 years of age and older	thalidomide 50 mg capsule	19/10/2012	First Review Completed
Tivicay For the treatment of human immunodeficiency virus (HIV)	dolutegravir sodium 50 mg tablet	05/05/2015	First Review Completed
TOBI PODHALER For the management of cystic fibrosis (CF) patients aged 6 years or older with chronic pulmonary Pseudomonas aeruginosa infections	tobramycin 28 mg capsule (tobramycin inhalation powder for oral inhalation only)	30/05/2012	Second Review Completed
TOBI PODHALER Is indicated for the management of cystic fibrosis (CF) patients aged 6 years or older with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections	tobramycin 28 mg capsule (tobramycin inhalation powder for oral inhalation only)	06/07/2016	First Review Completed
Toctino For the treatment of severe chronic hand eczema refractory to high potency topical corticosteroids in adults	alitretinoin 10 mg and 30 mg soft capsule	23/04/2013	Reconsideration Completed
TOUJEO DoubleSTAR For once-daily subcutaneous administration in the treatment of adult patients (â‰¥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 (â‰¥18 years) with Type 1 or Type 2 diabetes mellitus who require basal (long-acting) insulin for glycemic control	insulin glargine 300 unit/mL [1.5mL (450IU) prefilled pen] subcutaneous solution	20/09/2018	First Review Completed
Toviaz For the treatment of patients with overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence, or any combination of these symptoms	fesoterodine fumarate 4 mg and 8 mg tablet	23/04/2013	First Review Completed
TRADENAME For the treatment of moderately to severely active Rheumatoid Arthritis (RA)	upadacitinib 15 mg extended-release tablets	18/11/2019	Active
Trajenta For treatment in adults patients with type 2 diabetes mellitus to improve glycemic control	linagliptin 5 mg tablet	21/09/2012	First Review Completed
Travatan Z Intraocular pressure	travoprost 0.0004% w/v ophthalmic solution	21/08/2009	First Review Completed
Trazimera For the treatment of breast and gastric cancers, according to clinical criteria	TRASTUZUMAB 440 mg lyophilized powder per vial and 150 mg lyophilized powder per vial	15/11/2019	First Review Completed
Trazimera Metastatic Breast Cancer	TRASTUZUMAB 440 mg/vial and 150 mg/vial IV, powder for solution	15/09/2022	First Review Completed
Treanda Relapsed indolent B-cell non-Hodgkin lymphoma (NHL) who did not respond to or progressed during or shortly following treatment with a rituximab regimen	bendamustine hydrochloride 25 mg/ vial and 100 mg/ vial	31/05/2013	First Review Completed
Treanda Symptomatic chronic lymphocytic leukemia (CLL) who have received no prior treatment First line treatment of indolent non-Hodgkin lymphoma and mantle cell lymphoma	bendamustine hydrochloride 25 mg/ vial and 100 mg/ vial	31/05/2013	First Review Completed
Treanda In combination with rituximab (BR) for treatment of previously untreated CLL patients	bendamustine hydrochloride 25 mg/8 mL and 100 mg/20 mL lyophilized powder for IV injection single use vials	26/06/2018	First Review Completed
Trelegy Ellipta For the long-term, once daily, maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema	fluticasone furoate & umeclidiunium 62.5 mg & 25 mg, dry powder inhaler	20/09/2019	First Review Completed
Trelstar The palliative treatment of hormone dependent advanced carcinoma of the prostate gland	triptorelin pamoate 22.5 mg powder for suspension, sustained-release	21/11/2014	First Review Completed
Tremfya For the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy	GUSELKUMAB 100 mg/mL solution, prefilled syringe	06/03/2018	Active
Tremfya For the treatment of adult patients with active psoriatic arthritis. Can be used alone or in combination with a conventional disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate)	GUSELKUMAB 100 mg/mL SC solution & 100 mg/mL patient controlled injector (SC solution)	02/09/2022	Active
Tresiba For once-daily treatment of adults with diabetes mellitus to improve glycemic control	insulin degludec 100 unit/mL and 200 unit/mL SC solution flextouch prefilled pen	20/09/2018	First Review Completed
Tresiba (Penfill) For once-daily treatment of adults with diabetes mellitus to improve glycemic control	insulin degludec 100 unit/mL solution (SC injection)	25/01/2023	Active
Triamcinolone Hexacetonide Injectable Suspension For intra-articular, intrasynovial, or periarticular use in adults and adolescents for the symptomatic treatment of subacute and chronic inflammatory joint diseases including: – Rheumatoid arthritis – Juvenile Idiopathic Arthritis (JIA) – Osteoarthritis and post-traumatic arthritis – Synovitis, tendinitis, bursitis and epicondylitis	triamcinolone hexacetonide 20 mg/mL suspension, Intra-Articular/ Periarticular/ Intrasynovial Injection	28/05/2019	Active
Trikafta For the treatment of cystic fibrosis in patients who meet clinical criteria.	elexacaftor/ ivacaftor/ ivacaftor/ tezacaftor 100 mg/ 150 mg/ 75 mg/ 50 mg	22/09/2021	First Review Completed
Trikafta For the treatment of cystic fibrosis in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene	ELEXACAFTOR/TEZACAFTOR/IVACAFTOR AND IVACAFTOR 50 mg/25 mg /37.5 mg and 75 mg tablet	08/07/2022	First Review Completed
Trintellix For the treatment of major depressive disorder (MDD) in adults	vortioxetine hydrobromide 5 mg, 10 mg and 20 mg tablet	04/08/2015	File Closed
Trintellix For the treatment of major depressive disorder (MDD) in adults	vortioxetine hydrobromide 5 mg, 10 mg and 20 mg tablet	29/01/2021	First Review Completed
Trisenox Induction of remission and consolidation in patients with acute promyelocytic leukemia	arsenix trioxide 10mg/10mL (1mg/mL) ampoule	21/08/2014	First Review Completed
Triumeq Treatment of Human Immunodeficiency Virus (HIV-1) infection in adults	dolutegravir (as dolutegravir sodium)/ abacavir (as abacavir sulfate)/ lamivudine 50 mg/ 600 mg/ 300 mg tablet	24/06/2015	First Review Completed
Truetest Blood Glucose Test Strips To measure the concentration of glucose in the blood	glucose dehydrogenase – PQQ	07/01/2011	First Review Completed
Trulicity For the treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control; metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control	dulaglutide 0.75 mg/0.5 mL, 1.5 mg/0.5 mL single use pen, subcutaneous solution for injection	06/07/2016	Active
Trulicity For the treatment of adult patients with type 2 diabetes mellitus to improve glycemic control, in combination with metformin, when diet and exercise plus maximal tolerated dose of metformin do not achieve adequate glycemic control; metformin and a sulfonylurea, when diet and exercise plus dual therapy with metformin and a sulfonylurea do not achieve adequate glycemic control	dulaglutide 0.75 mg/0.5 mL, 1.5 mg/0.5 mL single use pen, subcutaneous solution for injection	06/07/2016	Active
Trurapi The treatment of patients with diabetes mellitus who require insulin for the control of hyperglycemia. Trurapi should normally be used in regimens together with an intermediate or long-acting insulin	INSULIN ASPART 100 units/mL, subcutaneous solution for injection	30/09/2021	First Review Completed
Trurapi â€¢ For the treatment of patients with diabetes mellitus who require insulin for the control of hyperglycemia. â€¢ Trurapi should normally be used in regimens together with an intermediate or long-acting insulin. â€¢ Trurapi (10 mL vials) may also be used for continuous subcutaneous insulin infusion (CSII) in pump systems which are licensed in Canada for Trurapi insulin infusion	INSULIN ASPART 100 units/mL vial, solution for subcutaneous injection	24/10/2022	Active
Truvada For use in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.	emtricitabine & tenofovir disoproxil fumarate 200 mg and 300 mg tablet	21/09/2017	First Review Completed
Truxima For the treatment of Rheumatoid Arthritis (RA) patients.	rituximab 10 mg/mL Intravenous Infusion, 100 mg (10 mL) or 500 mg (50 mL) single-use vials.	31/03/2020	First Review Completed
Truxima For the treatment of various cancers according to clinical criteria	rituximab 10 mg/mL Intravenous Infusion, 100 mg (10 mL) or 500 mg (50 mL) single-use vials.	31/03/2020	First Review Completed
Truxima In combination with glucocorticoids is indicated for the induction of remission in adult patients with severely active Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA).	rituximab 100 mg/10 mL and 500 mg/ 50 mL solution for intravenous infusion	30/09/2020	First Review Completed
Tukysa In combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and T-DM1, separately or in combination	TUCATINIB 50 mg and 150 mg tablet	06/10/2022	Active
Tudorza Genuair Long-term maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema	aclidinium bromide 400 mcg/ actuation	21/08/2014	First Review Completed
Twynsta For the treatment of mild to moderate essential hypertension where combination therapy is appropriate	telmisartan/ amlodipine besylate 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg and 80 mg/10 mg tablet	21/02/2012	First Review Completed
Twynsta, Pre-Notice of Compliance For the treatment of mild to moderate essential hypertension where combination therapy is appropriate	telmisartan/ amlodipine besylate 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg and 80 mg/10 mg tablet	12/08/2011	Withdrawn
Tykerb Advanced or metastatic breast cancer which overexpress Her2	lapatinib ditosylate 250 mg tablet	04/01/2012	Reconsideration Completed
Tykerb In combination with letrozole for the treatment of post-menopausal patients with hormone receptor positive metastatic breast cancer, whose tumours overexpress the ErbB2 (HER2) receptor, and who are suitable for endocrine therapy.	lapatinib ditosylate 250 mg tablet	27/11/2013	First Review Completed
Uloric To lower serum uric acid levels in patients with gout	febuxostat 80 mg tablet	27/03/2012	Reconsideration Completed
Ultibro Breezhaler For treatment of chronic obstructive pulmonary disease	indacaterol maleate/ glycopyrronium bromide 110 mcg & 50 mcg inhalation powder hard capsule	24/06/2015	First Review Completed
Unituxin In combination with granulocyte-macrophage colony stimulating factor (GM-CSF), interleukin-@ (IL-s) and 13 cis-retinoic acid (RA), for the treatment of high-risk neuroblastoma in pediatric patients who achieve at least a partial response to prior first-line multi-agent, multimodality therapy.	dinutuximab 3.5 mg/mL IV solution	26/02/2019	Active
Uptravi For the long-term treatment of idiopathic pulmonary arterial hypertension (iPAH), heritable pulmonary arterial hypertension (HPAH), PAH associated with connective tissue disorders and PAH associated with congenital heart disease, in adult patients with WHO functional class (FC) II-III to delay disease progression	selexipag 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400 mcg and 1600 mcg FC tablet	26/06/2018	First Review Completed
Vagifem LD Vaginal atrophy due to estrogen deficiency	estradiol hemihydrate 10 mcg tablet	08/09/2011	First Review Completed
Vectibix For the treatment of patients with wild-type RAS metastatic colorectal cancer in first line treatment setting in combination with FOLFOX	panitumumab 100 mg/5mL solution for infusion	31/10/2017	First Review Completed
Vectibix In combination with chemotherapy, for the first-line treatment of mCRC patients with left sided primary tumours that express wild-type RAS	panitumumab 100 mg/5mL and 400 mg/20 mL (20 mg/mL) solution for infusion	05/03/2018	Active
Velcade Mantle cell lymphoma, relapsed or refractory to at least one prior therapy	bortezomib 3.5 mg powder for injection	13/05/2009	First Review Completed
Velcade First – line treatment of multiple myeloma	bortezomib 3.5 mg powder for injection	13/05/2009	First Review Completed
Velcade Combination therapy in pre-autologous stem cell transplantation (ASCT) and monotherapy in post-ASCT in patients with Multiple Myeloma	bortezomib 3.5 mg powder for injection	30/11/2015	First Review Completed
Velphoro For the treatment of hyperphosphatemia associated with end-stage renal disease according to clinical criteria.	sucroferric oxyhydroxide 500 mg iron (equivalent to 2500 mg sucroferric oxyhydroxide) chewable tablets	26/02/2020	First Review Completed
Vemlidy Treatment of chronic hepatitis B in adults with compensated liver disease	tenofovir alafenamide hemifumarate 25 mg tablet	06/09/2018	Active
Venclexta As monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior therapy, or patients with CLL without 17p deletion who have received at least one prior therapy and for whom there are no other available treatment options	venetoclax 10 mg, 50 mg, 100 mg FC tablet and 10 mg/ 50 mg/ 100 mg FC tablet, starter kit	02/05/2019	First Review Completed
Venclexta For the use as monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and who have failed a B-Cell Receptor Inhibitor (BCRi)	venetoclax 10 mg, 50 mg, 100 mg FC tablet and 10 mg/ 50 mg/ 100 mg FC tablet, starter kit	16/03/2020	First Review Completed
Venclexta In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.	venetoclax 10 mg, 50 mg, and 100 mg tablets	16/03/2020	First Review Completed
Venclexta In combination with obinutuzumab for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL)	venetoclax 10 mcg, 50 mcg, 100 mcg FC Tablet, 10 mcg/ 50 mg/ 100 mcg FC Tablet, starter kit	06/05/2022	First Review Completed
Venclexta In combination with azacitidine for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.	venetoclax 10 mcg, 50 mcg, 100 mcg FC Tablet, 10 mcg/ 50 mg/ 100 mcg FC Tablet, starter kit	31/05/2021	Active
Verkazia For the treatment of severe vernal keratoconjunctivitis according to clinical criteria.	cyclosporine 0.1% w/v topical ophthalmic emulsion	03/03/2021	First Review Completed
Verzenio For the treatment of (HR)-positive, human epidermal growth factor receptor 2 (HER2)- negative advanced or metastatic breast cancer: -In combination with an aromatase inhibitor in postmenopausal women as initial endocrine based therapy. -In combination with fulvestrant in women with disease progression following endocrine therapy. Pre- or perimenopausal women must also be treated with a gonadotropin-releasing hormone agonist.	abemaciclib 50 mg, 100 mg and 150mg tablet	24/09/2019	Active
Viacoram For the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate	perindopril arginine & amlodipine 3.5 mg/2.5 mg, 7 mg & 5 mg and 14 mg & 10 mg tablet	09/03/2017	Active
Viberzi For the treatment of irritable bowel syndrom (IBS-D) with diarrhea in adults	eluxadoline 75 mg and 100 mg tablets	25/07/2018	Active
Victoza Treatment of adults with Type 2 diabetes	liraglutide 6 mg/mL solution for injection	30/05/2012	First Review Completed
Victrelis, Pre-Notice of Compliance Treatment of chronic hepatitis C genotype 1 infection in adult patients	boceprevir 200 mg capsule	04/01/2012	First Review Completed
Vidaza, Pre-Notice of Compliance Myelodysplastic syndrome	azacitidine 100 mg/vial lyophilized powder	30/06/2010	First Review Completed
Vimizim Indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis IVA (Morquio A syndrome, or MPS IVA)	elsolfase alfa 1 mg/mL intravenous solution	30/07/2015	First Review Completed
Vimizim Indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis IVA (Morquio A syndrome, or MPS IVA)	elsolfase alfa 5 mg/5 mL solution for intravenous infusion	13/06/2016	Active
Vimpat As adjunctive therapy for adult patients with epilepsy	lacosamide 50 mg, 100 mg, 150 mg and 200 mg FC tablet	01/05/2012	First Review Completed
Viramune XR Treatment of HIV-1 infection in combination with other antiretroviral agents	nevirapine 400 mg ER tablet	19/07/2012	First Review Completed
Viread Chronic hepatitis B in adults	tenofovir disoproxil fumarate 300 mg tablet	16/06/2009	First Review Completed
Visanne For the management of pelvic pain associated with endometriosis	dienogest 2 mg tablet	19/07/2012	First Review Completed
Vitrakvi For the treatment of adult and pediatric patients with solid tumours that: – have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, – are metastatic or where surgical resection is likely to result in severe morbidity, and – have no satisfactory treatment options.	larotrectinib sulfate 25 mg and 100 mg capsules, 20 mg/mL oral solution	12/02/2020	Active
Vizimpro For the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR-activating mutations.	dacomitinib 15 mg, 30 mg, and 45 mg tablets	07/06/2019	Active
Vocabria AND Cabenuva VOCABRIA (cabotegravir tablets) is indicated, in combination with EDURANT (rilpivirine tablets), as a complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically stable and suppressed (HIV1 RNA less than 50 copies/mL) as: – an oral lead-in to assess tolerability of cabotegravir prior to initiating CABENUVA – oral bridging therapy for missed CABENUVA injections CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is indicated: – as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL).	cabotegravir and cabotegravir and rilpivirine 30 mg tablet, AND 200 mg/mL / 300 mg/ mL (400 mg/ 2mL and 600 mg/ 2mL) Kit, IM, ER injectable suspension, 200 mg/ mL / 300 mg/ mL (600 mg/ 3mL and 900 mg/ 3mL) Kit, IM, ER injectable suspension	25/11/2020	Active
Vacabria In combination with rilpivirine tablets, as a complete regimen for short-term treatment of Human Immunodeficiency Virus-Type 1 (HIV-1) infection in adult patients who are virologically stable and suppressed (defined as HIV-1 ribonucleic acid [RNA] level [viral load] of less than 50 copies/mL) as: – An oral lead-in to assess tolerability of cabotegravir prior to initiating Cabenuva (cabotegravir/rilpivirine) injections; – Oral bridging therapy for missed Cabenuva injections; The prescriber must be approved for the Facilitated Access to HIV/AIDS Drug Products mechanism.	cabotegravir 30 mg tablet	30/11/2021	First Review Completed
Volibris Pulmonary arterial hypertension	ambrisentan 5 mg and 10 mg tablet	26/03/2009	First Review Completed
Vosevi For the treatment of chronic hepatitis C virus (HCV) infection in adult patients, without cirrhosis or with compensated cirrhosis, who have: - genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor; - genotype 1, 2, 3, or 4 infection and have been previously treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.	sofosbuvir/ velpatasvir/ voxilaprevir 400 mg/ 100 mg/ 100 mg tablet	05/04/2018	First Review Completed
Votrient The treatment of patients with metastatic renal cell carcinoma	pazopanib hydrochloride 200 mg tablet	23/01/2014	Reconsideration Completed
Votrient Treatment of advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy	pazopanib hydrochloride 200 mg tablet	22/04/2013	First Review Completed
VPRIV Long-term enzyme replacement therapy for pediatric and adult patients with type 1 Gaucher disease	velaglucerase alfa 400U/vial powder for solution for injection	04/01/2012	First Review Completed
Vraylar Acute management of manic or mixed episodes associated with bipolar I disorder in adults, and the acute management of depressive episodes associated with bipolar I disorder in adults.	CARIPRAZINE 1.5 mg and 3 mg capsule	06/06/2022	Active
Vraylar For the acute and long-term maintenance treatment of schizophrenia in adults.	CARIPRAZINE 1.5 mg and 3 mg capsule	17/03/2022	Active
Vascepa To reduce the risk of ischemic cardiovascular events/ death due to cardiovascular event non-fatal myocardial infarction, non-fatal stroke, coronary revascularization and unstable angina) in statin-treated patients, with elevated triglycerides and other risk factors such as established cardiovascular disease or at high risk for cardiovascular disease.	icosapent ethyl 1 g capsule	21/07/2022	First Review Completed
Vyndaqel For the treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis, wild-type or hereditary, to reduce cardiovascular mortality and cardiovascular-related hospitalization.	tafamidis meglumine 20 mg capsule	15/09/2022	First Review Completed
Vyndamax For the treatment of adult patients with cardiomyopathy due to transthyretin-mediated amyloidosis (ATTR-CM), wild type or hereditary, to reduce cardiovascular mortality and cardiovascular related hospitalization.	tafamadis 61 mg capsule	15/09/2022	First Review Completed
Vyvanse Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years	lisdexamfetamine dimesylate 30 mg and 50 mg capsule	16/06/2011	First Review Completed
Vyvanse Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 to 12 years	lisdexamfetamine dimesylate 20 mg, 40 mg and 60 mg capsule	16/06/2011	First Review Completed
Vyvanse Attention Deficit Hyperactivity Disorder (ADHD)	lisdexamfetamine dimesylate 10 mg capsule	26/06/2018	First Review Completed
Vyvanse For the treatment of Attention Deficit Hyperactivity Disorder (ADHD).	lisdexamfetamine dimesylate 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, chewable tablets (new dosage form)	31/03/2020	First Review Completed
Vyzulta For the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.	latanoprostene bunod 0.024 % / w/v ophthalmic solution	20/12/2019	First Review Completed
Xalkori Monotherapy for anaplastic lymphoma kinase activated or metastatic non-small cell lung cancer	crizotinib 200 mg and 250 mg capsule	19/09/2013	Reconsideration Completed
Xalkori Monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC)	crizotinib 200 mg and 250 mg capsule	05/01/2016	First Review Completed
Xamiol Psoriasis	calcipotriol/ betamethasone 50 mcg/g and 0.5 mg/g topical gel	19/05/2011	First Review Completed
Xarelto Prevention of venous thromboembolic events (VTE)	rivaroxaban 10 mg FC tablet	25/07/2012	First Review Completed
Xarelto Prevention of stroke and systemic embolism in patients with atrial fibrillation, in whom anticoagulation is appropriate	rivaroxaban 15 mg and 20 mg FC tablet	25/07/2012	First Review Completed
Xarelto For the treatment of deep vein thrombosis (DVT) in patients without symptomatic pulmonary embolism	rivaroxaban 15 mg and 20 mg FC tablet	11/12/2012	First Review Completed
Xarelto For the treatment of pulmonary embolism (PE)	rivaroxaban 15 mg and 20 mg FC tablet	30/11/2015	First Review Completed
Xarelto Xarelto 2.5 mg FC tablet in combination with 75 mg – 100 mg acetylsalicylic acid (ASA), is indicated for the prevention of stroke, myocardial infarction and cardiovascular death, and for the prevention of acute limb ischemia and mortality in patients with coronary artery disease (CAD) with or without peripheral artery disease (PAD).	rivaroxaban 2.5 mg FC tablet	20/12/2019	First Review Completed
Xarelto, Pre-Notice of Compliance Prevention of venous thromboembolic events (VTE)	rivaroxaban 10 mg FC tablet	18/11/2008	File Closed
Xeljanz In combination with methotrexate for reducing the signs and symptoms of rheumatoid arthritis in adult patients with moderately to severely active RA who have had an inadequate response to methotrexate	tofacitinib citrate 5 mg tablet	28/03/2017	First Review Completed
Xeljanz Use in combination with methotrexate, for the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease modifying anti-rheumatic drugs (DMARDs) treatment regimens	tofacitinib citrate 11 mg, extended-release oral tablets	30/05/2018	Active
Xeljanz For the treatment of adult patients with moderately to severely active ulcerative colitis (UC) with an inadequate response, loss of response or intolerance to either conventional UC therapy or a TNFÎ± inhibitor.	tofacitinib citrate 5 mg and 10 mg tablets	30/09/2020	First Review Completed
Xeloda First-line and second-line treatment of metastatic colorectal cancer	capecitabine 150 mg and 500 mg tablet	05/02/2009	First Review Completed
Xeomin Symptomatic management of blepharospasm	clostridium botulinum neurotoxin type A 100LD50 units per vial powder for solution for injection	19/05/2011	First Review Completed
Xeomin Symptomatic management of cervical dystonia	clostridium botulinum neurotoxin type A 100LD50 units per vial powder for solution for injection	19/05/2011	First Review Completed
Xeomin Symptomatic management of post-stroke spasticity of the upper limb	clostridium botulinum neurotoxin type A 100LD50 units per vial powder for solution for injection	29/03/2012	Reconsideration Completed
Xeomin For the treatment of hypertonicity disorders	clostridium botulinum neurotoxin type A 50 LD50 units per vial	28/11/2013	First Review Completed
Xermelo For the treatment of refractory carcinoid syndrome diarrhea, in combination with somatostatin analogue (SSA) therapy, in patients inadequately controlled by SSA therapy alone.	telotristat etiprate 250 mg tablet	30/01/2019	Active
Xpovio In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.	SELINEXOR 20 mg FC tablets	21/06/2022	Active
Xydalba For the treatment of adult patients with acute bacterial skin and skin structure infections caused by susceptible isolates of specific gram-positive microorganisms.	DALBAVANCIN HYDROCHLORIDE 500 mg/vial lyophilized powder for solution, intravenous	10/05/2022	Active
Xgeva Reducing the risk of developing skeletal-related events in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumours	denosumab 120 mg/ 1.7 mL solution in a single-use vial	17/04/2012	First Review Completed
Xiaflex For the treatment of adult patients with Dupuytren’s contracture with a palpable cord.	collagenase clostridium histolyticum 0.9 mg/vial lyophilized powder for injection	21/01/2015	Reconsideration Completed
Xigduo Treatment of Type 2 diabetes	dapagliflozin & metformin HCl 5 mg/850 mg and 5 mg/1000 mg tablet	08/08/2017	First Review Completed
Xofigo For the treatment of patients with castration-resistance prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.	radium RA 223 dichloride 1000 kBq/ mL/ solution for injection	22/01/2015	First Review Completed
Xolair Moderate to severe asthma	OMALIZUMAB 150 mg powder for solution for injection	18/01/2012	Reconsideration Completed
Xolair Treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment	OMALIZUMAB 150 mg powder for solution for injection	23/05/2017	First Review Completed
Xolair For the treatment of patients (6 years of age and above) with moderate to severe persistent asthma, who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids, and for the treatment of patients 12 years of age and above with chronic idiopathic urticaria (CIU) who remain symptomatic despite H1 antihistamine treatment	OMALIZUMAB 150 mg powder for solution for injection	03/11/2021	First Review Completed
Xolair IgE-Neutralizing Antibody (Anti-IgE)	OMALIZUMAB 75 mg/0.5 mL solution for subcutaneous injection, pre-filled syringe	06/12/2022	Active
Xospata For the treatment of adult patients diagnosed with relapsed or refractory FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukemia (AML) according to clinical criteria.	gilteritinib 40 mg tablet	12/01/2021	First Review Completed
Xtandi For the treatment of patients with metastatic castration-resistant prostate cancer in the setting of medical or surgical castration who have received docetaxel therapy	enzalutamide 40 mg capsule	28/11/2013	First Review Completed
Xtandi For the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have not received prior chemotherapy.	enzalutamide 40 mg capsule	30/11/2015	First Review Completed
Xtandi In combination with androgen deprivation therapy (ADT) for the treatment of high risk, nonmetastatic CRPC patients.	enzalutamide 40 mg capsule	10/06/2020	First Review Completed
Xtandi For the treatment of metastatic castration-sensitive prostate cancer according to clinical criteria.	enzalutamide 40 mg capsule	12/01/2021	First Review Completed
Xultophy As an adjunct to lifestyle modifications, for the once-daily treatment of adults with type 2 diabetes mellitus to improve glycemic control in combination with metformin, with or without sulfonylurea, when these combined with basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily), do not provide adequate glycemic control.	insulin degludec + liraglutide injection 100 units/mL + 3.6 mg/mL subcutaneous solution for injection in a pre-filled pen	21/06/2019	Active
Xyrem Narcolepsy	sodium oxybate 500 mg/mL oral solution	10/07/2009	Reconsideration Completed
YAZ Oral contraceptive/acne therapy	ethinyl estradiol/ drospirenone 3.0mg / 0.020mg FC tablets	25/09/2009	First Review Completed
Yuflyma Biological Response Modifier	ADALIMUMAB 100 mg/mL SC solution, prefilled syringe and pre-filled pen (auto-injector)	31/05/2022	First Review Completed
Yuflyma Biological Response Modifier	ADALIMUMAB 100 mg/mL solution for subcutaneous injection	28/12/2022	Active
Yervoy For the treatment of unresectable or metastatic melanoma	ipilimumab 5 mg/mL IV solution	24/06/2015	First Review Completed
Yervoy For the treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic therapy for advanced disease	ipilimumab 5 mg/ mL intravenous infusion	21/09/2012	First Review Completed
Yervoy and Opdivo OPDIVO (nivolumab) in combination with YERVOY (ipilimumab) and 2 cycles of chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no known EGFR or ALK genomic tumor aberrations.	ipilimumab and nivolumab 5 mg/mL IV solution, 40 mg/ 4mL solution and 100 mg/10mL solution	18/12/2020	Active
Opdivo In combination with fluoropyrimidine- and platinum containing chemotherapy, is indicated for the treatment of adult patients with HER2 negative advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. Adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer in patients who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT)	NIVOLUMAB 10 mg/mL (40 mg/4 mL) intravenous solution and 10 mg/mL (100 mg/10 mL) intravenous solution	10/11/2022	First Review Completed
Opdivo and Yervoy OPDIVO, in combination with ipilimumab, is indicated for the treatment of adult patients with unresectable malignant pleural mesothelioma (MPM) who have not received prior systemic therapy for MPM.	nivolumab and ipilimumab 40 mg/4 mL (10 mg/mL), 100 mg/10 mL (10 mg/mL) AND 5 mg/mL (50 mg/10 mL), 5 mg/mL (200 mg/40 mL) IV solution	12/05/2022	First Review Completed
Yescarta YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for: – the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.	axicabtagene ciloleucel 200000000 CELLS / BAG	24/07/2020	Active
Yondelis For the treatment of patients with metastatic liposarcoma or leiomyosarcoma after failure of prior anthracycline and ifosfamide chemotherapy	trabectedin 1 mg/ vial intravenous powder for solution	06/06/2016	Active
Zaltrap In combination with an irinotecan-fluoropyrimidine-based (FOLFIRI) chemotherapy for patients with metastatic colorectal cancer (mCRC) previously treated with an oxaliplatin-containing regimen	aflibercept 25 mg/ mL IV solution	30/11/2015	File Closed
Zaxine Reduction in risk of overt hepatic encephalopathy recurrence in patients â‰¥18 years of age	rifaximin 550 mg tablet	06/07/2016	First Review Completed
Zejula For the maintenance treatment of newly diagnosed or recurrent high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer according to clinical criteria.	niraparib 100 mg capsules	21/12/2021	First Review Completed
Zejula Monotherapy for the maintenance treatment of adult patients with advanced epithelial ovarian cancer are in a complete or partial response to first-line platinum-based chemotherapy.	niraparib 100 mg capsules	08/04/2021	Active
Zelboraf For the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma	vemurafenib 240 mg tablet	30/11/2015	Reconsideration Completed
Zenhale For the treatment of asthma, in patients 12 years of age and older with reversible obstructive airway disease	mometasone furoate/ formoterol 50mcg/ 5mcg, 100mcg/ 5mcg and 200mcg/ 5mcg metered dose inhaler	21/02/2012	First Review Completed
Zepatier For the treatment of Chronic Hepatitis C (CHC) genotypes 1, 3, or 4 infections in adults	elbasvir & grazoprevir 50 mg & 100 mg tablet	26/06/2018	First Review Completed
Zeposia For the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations.	ozanimod HCl 0.92 mg gelatin capsule, 0.23 mg/ 0.46 mg gelatin capsule (kit)	06/11/2020	Active
Wakix For the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.	PITOLISANT HCl 5 mg and 20 mg tablet	10/03/2022	Active
Wegovy As an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, or obstructive sleep apnea.	SEMAGLUTIDE 0.25 mg/pen, 0.5 mg/pen, 1 mg/pen, 1.7 mg/pen, 2.4 mg/pen, 1 mg/pen, 2 mg/pen, 4 mg/pen, 6.8 mg/pen & 9.6 mg/pen SC pre-filled pen	10/08/2022	Active
Waymade-Trientine For the treatment of patients with Wilson's Disease who are intolerant to penicillamine.	TRIENTINE HYDROCHLORIDE 250 mg capsule	11/08/2022	First Review Completed
Zepzelca For the treatment of adult patients with Stage III or metastatic small cell lung cancer (SCLC) who have progressed on or after platinum-containing therapy.	LURBINECTEDIN 4 mg per vial (0.5 mg/mL) IV, powder for solution	20/05/2022	Active
Zeulide Depot For the palliative treatment of advanced and/or metastatic prostate cancer.	leuprolide acetate 3.75 mg [1-Month] and 22.5 mg [3-Month], Intramuscular Injection.	04/11/2019	Active
Ziextenxo To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.	pegfilgrastim 6 mg (10 mg/ml), sterile solution for injection	28/08/2020	First Review Completed
Zinbryta For the treatment of adult patients with active relapsing remitting multiple sclerosis (RRMS) who have had an inadequate response to, or who are unable to tolerate, one or more therapies indicated for the treatment of multiple sclerosis (MS).	daclizumab beta 150 mg/mL solution for injection	08/08/2017	Active
Zirabev For the treatment of various cancers, according to clinical criteria.	bevacizumab 100 mg (25 mg/mL solution for injection) and 400 mg (25 mg/mL solution for injection) intravenous solution.	31/10/2019	First Review Completed
Zolgensma For the treatment of spinal muscular atrophy (SMA) in patients who meet clinical criteria.	onasemnogene abeparvovec 2 x 1013 vector genomes/mL, solution for intravenous infusion	29/10/2021	First Review Completed
Zometa Bone metastases due to renal cell carcinoma (mRCC)	zoledronic acid 4 mg/5 mL solution	04/10/2010	First Review Completed
Zometa Adjuvant treatment of hormone receptor-positive early breast cancer in pre-menopausal women	zoledronic acid 4 mg/5 mL solution	04/10/2010	First Review Completed
Zometa For the treatment of patients with osteolytic lesions of multiple myeloma	zoledronic acid 4 mg/5 mL solution	31/07/2013	First Review Completed
Zyclara Treatment of actinic keratoses	imiquimod 3.75% topical cream	05/12/2012	Withdrawn
Zydelig In combination with rituximab for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL)	idelalisib 100 mg and 150 mg tablet	28/03/2017	First Review Completed
Zydelig As a monotherapy for the treatment of patients with follicular lymphoma (FL) who have received at least two prior systemic regimens and are refractory to both rituximab and an alkylating agent	idelalisib 100 mg and 150 mg tablet	03/11/2016	File Closed
Zykadia As monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib	ceritinib 150 mg capsules	04/03/2016	First Review Completed
Zykadia As monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib	ceritinib 150 mg capsules	22/11/2018	First Review Completed
Zytiga In combination with prednisone for the treatment of metastatic prostate cancer (castration-resistant prostate cancer) in patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy	abiraterone acetate 250 mg tablet	30/11/2015	First Review Completed
Zytiga For the treatment of metastatic castrate-resistant prostate cancer (mCRPC)	abiraterone acetate 500 mg FC tablet	06/06/2017	First Review Completed
Zytiga, Pre-Notice of Compliance For the treatment of metastatic prostate cancer in patients who have received prior chemotherapy	abiraterone acetate 250 mg tablet	04/01/2012	First Review Completed

See Also:

Ministry Status: Recovery

Drug Submissions

Status For Single-Source Submissions

For More Information