New Drug Indication Approvals

New drug indication approval - March 2025

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Therapeutic Products

15 March 2025

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For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

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Product Name	IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML
Active Ingredient (Strength)	Durvalumab(50 mg/ml)
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	20/03/2025
Indications: IMFINZI in combination with carboplatin and paclitaxel is indicated for the first-line treatment of patients with advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by treatment with ∙ IMFINZI as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR). ∙ IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).

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Product Name	LYNPARZA FILM-COATED TABLET 100MG, LYNPARZA FILM-COATED TABLET 150MG
Active Ingredient (Strength)	Olaparib(100mg), Olaparib(150mg)
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	20/03/2025
Indications: Lynparza in combination with durvalumab is indicated for the: ∙ maintenance treatment of adult patients with advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.

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Product Name	ULTOMIRIS CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/ML
Active Ingredient (Strength)	Ravulizumab(100 mg/mL)
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	27/03/2025
Indications: ULTOMIRIS is indicated for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

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Product Name	JARDIANCE DUO FILM COATED TABLET 5MG/500MG, JARDIANCE DUO FILM COATED TABLET 12.5MG/500MG, JARDIANCE DUO FILM COATED TABLET 12.5MG/850MG, JARDIANCE DUO FILM COATED TABLET 12.5MG/1000MG
Active Ingredient (Strength)	Empagliflozin(5 mg),Metformin Hydrochloride(500mg), Empagliflozin(12.5 mg),Metformin Hydrochloride(500mg), Empagliflozin(12.5 mg),Metformin Hydrochloride(850mg), Empagliflozin(12.5 mg),Metformin Hydrochloride(1000mg)
Product Registrant	BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
Date of Approval	18/03/2025
Indications: JARDIANCE DUO is indicated as an adjunct to diet and exercise to improve glycaemic control in children aged 10 years and above with type 2 diabetes mellitus. ∙when treatment with both empagliflozin and metformin is appropriate ∙inadequately controlled with metformin alone or in combination with insulin (see section Clinical Trials) ∙already treated with empagliflozin and metformin co-administered as separate tablets

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Product Name	JARDIANCE FILM-COATED TABLETS 10MG, JARDIANCE FILM-COATED TABLET 25MG
Active Ingredient (Strength)	Empagliflozin(10.0 mg), Empagliflozin(25.00mg)
Product Registrant	BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
Date of Approval	18/03/2025
Indications: Type 2 diabetes mellitus JARDIANCE is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults and children aged 10 years and above as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. Add-on combination therapy In combination with other glucose–lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). Add-on combination in patients with established cardiovascular disease JARDIANCE is indicated as an adjunct to diet, exercise and standard care therapy to reduce the incidence of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease who have inadequate glycemic control (see section 5.1).

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Product Name	NEFEGAN MODIFIED RELEASE CAPSULE 4MG
Active Ingredient (Strength)	Budesonide(4.00 mg)
Product Registrant	EVEREST MEDICINES (SINGAPORE) PTE. LTD.
Date of Approval	11/03/2025
Indications: NEFEGAN is indicated to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g).

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Product Name	KEYTRUDA SOLUTION FOR INFUSION 25MG/ML
Active Ingredient (Strength)	Pembrolizumab(25.0 mg/mL)
Product Registrant	MSD PHARMA (SINGAPORE) PTE. LTD.
Date of Approval	07/03/2025
Indications: KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma. KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as monotherapy, is indicated for the treatment of patients with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy. *Evaluated as part of Project Orbis.

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Product Name	ALECENSA HARD CAPSULE 150MG
Active Ingredient (Strength)	Alectinib Hydrochloride 161.33 mg eqv. Alectinib(150 mg)
Product Registrant	ROCHE SINGAPORE PTE. LTD.
Date of Approval	21/03/2025
Indications: Alecensa as monotherapy is indicated as adjuvant treatment following complete tumour resection for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence (see section 3.1.2). *Evaluated as part of Project Orbis.

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Product Name	COPLAVIX FILM-COATED TABLET 75 MG/100 MG
Active Ingredient (Strength)	(Acetylsalicylic acid layer) Acetylsalicylic acid (as Acetylsalicylic acid granulated with starch)(100 mg),(Clopidogrel layer) Clopidogrel (as Clopidogrel hydrogen sulfate form II)(75 mg)
Product Registrant	SANOFI-AVENTIS SINGAPORE PTE. LTD.
Date of Approval	03/03/2025
Indications: CoPlavix is indicated for the secondary prevention of atherothrombotic events in patients suffering from acute coronary syndrome: - Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention (PCI). - ST segment elevation acute myocardial infarction (STEMI) in patients undergoing PCI (including patients undergoing a stent placement) or medically treated patients eligible for thrombolytic/ fibrinolytic therapy

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