New Drug Indication Approvals

New drug indication approval - August 2024

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Healthcare professional

Industry member

Product type

Therapeutic Products

11 October 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	SOLIRIS CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/VIAL
Active Ingredient (Strength)	Eculizumab (300 mg / vial)
Product Registrant	ASTRAZENECA SINGAPORE PTE LTD
Date of Approval	21/08/2024
Indications: SOLIRIS is indicated in adults for the treatment of patients with: • Refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive (see section 5.1). • Neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive (see section 5.1).

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Product Name	ROMIPLATE POWDER FOR SOLUTION FOR INJECTION 250 ΜG/VIAL
Active Ingredient (Strength)	ROMIPLOSTIM 375 μg/vial (250 μg/vial (deliverable amount))
Product Registrant	KYOWA KIRIN ASIA PACIFIC PTE. LTD.
Date of Approval	15/08/2024
Indications: Romiplate is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).

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Product Name	VABYSMO SOLUTION FOR INJECTION 6MG/0.05ML
Active Ingredient (Strength)	Faricimab (6.00mg/0.05ml)
Product Registrant	ROCHE SINGAPORE PTE. LTD.
Date of Approval	06/08/2024
Indications: Vabysmo is indicated for the treatment of adult patients with: · macular edema secondary to retinal vein occlusion (RVO) (see section 3.1.2 Clinical Efficacy Studies).

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