New Drug Indication Approvals

New drug indication approval - February 2025

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Therapeutic Products

14 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	PADCEV® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/VIAL, PADCEV® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 30MG/VIAL
Active Ingredient (Strength)	Enfortumab vedotin(20.0 mg/vial), Enfortumab vedotin(30.0 mg/vial)
Product Registrant	ASTELLAS PHARMA SINGAPORE PTE. LTD.
Date of Approval	28/02/2025
Indications: Padcev, in combination with pembrolizumab, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).

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Product Name	OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10 MG/ML
Active Ingredient (Strength)	Nivolumab(10mg/mL)
Product Registrant	BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
Date of Approval	10/02/2025
Indications: Melanoma OPDIVO as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Adjuvant treatment of melanoma OPDIVO as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection (see section 5.1). Evaluated as part of Project Orbis

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Product Name	OPDIVO CONCENTRATE FOR SOLUTION FOR INFUSION 10 MG/ML
Active Ingredient (Strength)	Nivolumab(10mg/mL)
Product Registrant	BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
Date of Approval	25/02/2025
Indications: OPDIVO, in combination with cisplatin and gemcitabine, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. Evaluated as part of Project Orbis

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Product Name	VEMLIDY FILM COATED TABLET 25 MG
Active Ingredient (Strength)	Tenofovir Alafenamide Hemifumarate eqv Tenofovir Alafenamide(25.0mg)
Product Registrant	GILEAD SCIENCES SINGAPORE PTE. LTD.
Date of Approval	21/02/2025
Indications: VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease [see Clinical Studies (13)].

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Product Name	AREXVY POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION 120MCG/0.5ML
Active Ingredient (Strength)	RSVPreF3 antigen(120mcg/0.5mL)
Product Registrant	GLAXOSMITHKLINE PTE LTD
Date of Approval	28/02/2025
Indications: Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in: ∙ adults 60 years of age and older; ∙ adults 50 through 59 years of age who are at increased risk for RSV disease. Consideration should be given to official vaccine recommendations on the appropriate use.

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Product Name	WEGOVY 2.4 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 3.2 MG/ML, WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 1MG/0.5ML, WEGOVY 1.7 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 2.27 MG/ML, WEGOVY 1 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34 MG/ML, WEGOVY 0.5 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34 MG/ML, WEGOVY 0.25 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.68 MG/ML, WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.5MG/0.5ML, WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.25MG/0.5ML, WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.7MG/0.75ML, WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 2.4MG/0.75ML
Active Ingredient (Strength)	Semaglutide(3.2mg/ml), Semaglutide(1.0mg/0.5ml), Semaglutide(2.27mg/ml), Semaglutide(1.34mg/ml), Semaglutide(1.34mg/mL), Semaglutide(0.68mg/mL), Semaglutide(0.5mg/0.5ml), Semaglutide(0.25mg/0.5ml), Semaglutide(1.7mg/ 0.75ml), Semaglutide(2.4mg/ 0.75ml)
Product Registrant	NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Date of Approval	28/02/2025
Indications: Wegovy® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with ∙ obesity* and ∙ body weight above 60 kg. Treatment with Wegovy® should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose. *Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov)

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Product Name	RECTOGESIC OINTMENT 0.2% W/W
Active Ingredient (Strength)	GLYCERYL TRINITRATE(0.2% w/w)
Product Registrant	STEWARD CROSS PTE LTD
Date of Approval	27/02/2025
Indications: For relief of pain and to aid wound healing as part of post-operative management following haemorrhoidectomy.

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New drug indication approval - February 2025

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