New Drug Indication Approvals

New drug indication approval - April 2024

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Healthcare professional

Industry member

Product type

Therapeutic Products

2 July 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	ATGAM INJECTION 50 MG/ML
Active Ingredient (Strength)	HORSE GAMMA GLOBULIN(50 mg/ml)
Product Registrant	PFIZER PRIVATE LIMITED
Date of Approval	18/04/2024
Indications: ATGAM is indicated for use in adults and in children aged 2 years and older for the treatment of moderate to severe aplastic anemia in patients who are unsuitable for bone marrow transplantation.

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Product Name	KEYTRUDA SOLUTION FOR INFUSION 25MG/ML
Active Ingredient (Strength)	PEMBROLIZUMAB(25MG/ML)
Product Registrant	MSD PHARMA (SINGAPORE) PTE LTD
Date of Approval	29/04/2024
Indications: Keytruda, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.

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