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Summary Reports of Benefit-Risk Assessment

The reports contain a summary of the quality, safety and efficacy of approved new chemicals and biologics, and HSA's benefit-risk assessment for the approvals.

For the latest approved PI, please access the Online Register of Therapeutic Products.

Product name Active Ingredient(s) Product Registrant Approval date
Vitrakvi Hard Capsules 25mg and 100mg, Oral Solution 20mg/ml573 KB Larotrectinib Bayer (South East Asia) Pte Ltd 2020/08/17 
Balversa Film Coated Tablets 3mg, 4mg and 5mg468 KB
Erdafitinib Johnson & Johnson Pte Ltd 2020/08/07
Skyrizi Solution For Injection in Pre-Filled Syringe 75mg428 KB
Risankizumab Abbvie Pte Ltd 2020/07/06
Vizimpro Film Coated Tablet 15mg, 30mg and 45mg638 KB
Dacomitinib Monohydrate Pfizer Private Limited 2020/06/25
Lokelma Powder for Oral Suspension 5g and 10g478 KB
Sodium Zirconium Cyclosilicate AstraZeneca Singapore Pte Ltd 2020/06/22
Veklury Lyophilized Powder for IV Infusion 100mg and Solution for IV Infusion 5mg/ml196 KB
Remdesivir Gilead Sciences Singapore Pte Ltd 2020/06/10
Lutathera Solution for Infusion 370MBq/ml678 KB Lutetium (177Lu) oxodotreotide Novartis (Singapore) Pte Ltd 2020/06/01
Talzenna Capsules 0.25mg and 1mg824 KB
Talazoparib tosylate
Pfizer Private Limited
2020/05/20

Tukysa Film-Coated Tablets 50mg and 150mg1041 KB

*Evaluated as part of Project Orbis

Tucatinib Nyprax Pharma Pte Ltd 2020/05/19 

Ajovy Solution for Injection in Pre-filled Syringe 225mg/1.5ml552 KB

Fremanezumab
Drug Houses of Australia Pte Ltd
2020/05/08


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