New Drug Indication Approvals

New drug indication approval - July 2024

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

12 September 2024

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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	GLYPRESSIN SOLUTION FOR INJECTION, 1 MG/8.5 ML
Active Ingredient (Strength)	Terlipressin 0.85 mg/8.5 ml eqv Terlipressin acetate(1 mg/8.5 ml)
Product Registrant	FERRING PHARMACEUTICALS PRIVATE LIMITED
Date of Approval	10/07/2024
Indications: Treatment of patients with hepatorenal syndrome (HRS) Type 1 who are actively being considered for liver transplant (see sections 4.2 and 4.4 on the risks in special populations).

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Product Name	REXULTI FILM-COATED TABLETS 0.5MG, REXULTI FILM-COATED TABLETS 1MG, REXULTI FILM-COATED TABLETS 2MG, REXULTI FILM-COATED TABLETS 3MG
Active Ingredient (Strength)	BREXPIPRAZOLE(0.5mg), BREXPIPRAZOLE(1mg), BREXPIPRAZOLE(2mg), BREXPIPRAZOLE(3mg)
Product Registrant	LUNDBECK SINGAPORE PTE. LTD.
Date of Approval	24/07/2024
Indications: Treatment of agitation associated with Alzheimer’s dementia (AAD), who are unresponsive to non-pharmacological interventions.

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Product Name	PREVYMIS CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/ML, PREVYMIS FILM COATED TABLET 240MG, PREVYMIS FILM COATED TABLET 480MG
Active Ingredient (Strength)	Letermovir(20mg/ml), Letermovir(240.0mg), Letermovir(480.0mg)
Product Registrant	MSD PHARMA (SINGAPORE) PTE. LTD.
Date of Approval	01/07/2024
Indications: Prevymis is indicated for prophylaxis of CMV disease in CMV-seronegative adults who have received a kidney transplant from a CMV-seropositive donor [D+/R-].

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Product Name	HYRIMOZ SOLUTION FOR INJECTION IN PRE-FILLED PEN 40MG/0.8ML
Active Ingredient (Strength)	Adalimumab(40 mg/0.8 mL)
Product Registrant	NOVARTIS (SINGAPORE) PTE LTD
Date of Approval	18/07/2024
Indications: Pediatric Ulcerative Colitis Hyrimoz is indicated for inducing and maintaining clinical remission in pediatric patients 5 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

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Product Name	ULTRAVIST 300 INJECTION 300MG IODINE/ML ULTRAVIST 370 INJECTION 370MG IODINE/ML
Active Ingredient (Strength)	Iopromide eqv iodine (300mg/ml), Iopromide eqv iodine (370mg/ml)
Product Registrant	BAYER (SOUTH EAST ASIA) PTE LTD
Date of Approval	27/07/2024
Indications: For use in contrast-enhanced mammography to assess and detect known or suspicious lesions of the breast in adult women as an adjunct to mammography (with or without ultrasound).

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