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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
Vpriv Powder for Solution for Infusion 400units/vial483 KB
Velaglucerase alfa Takeda Pharmaceuticals (Asia Pacific) Pte Ltd 2021/02/24
Kesimpta Solution for Injection in Pre-filled Syringe 20mg/0.4ml, Pre-filled Pen 20mg/0.4ml1369 KB
Ofatumumab Novartis (Singapore) Pte Ltd 2021/02/05

Rozlytrek Hard Capsules 100mg, 200mg750 KB

Entrectinib Roche Singapore Pte Ltd 2021/01/27
Shingrix Powder and Suspension for Suspension for Injection 50 mcg/ 0.5 ml444 KB
[Antigen] Recombinant Varicella Zoster Virus glycoprotein E (gE) Glaxosmithkline Pte Ltd 2021/01/12
Sonazoid Powder and Solvent for Dispersion for Injection 16 μL/vial411 KB
Perfluorobutane (microbubbles) GE Healthcare 2021/01/06
Lixiana Film-Coated Tablets 15mg, 30mg and 60mg677 KB
Edoxaban Tosilate A. Menarini Singapore Pte Ltd 2020/12/18
Naldebain Extended Release Injection 75mg/ml815 KB
Dinalbuphine sebacate Intega Pte Ltd 2020/12/15
Adynovate Powder and Solvent for Solution for Injection 250IU, 500IU, 1000IU, 1500IU, 2000IU, 3000IU821 KB
Rurioctocog alfa pegol  Takeda Pharmaceuticals  2020/11/24
Spravato Nasal Spray 28mg1221 KB
Esketamine Johnson & Johnson Pte Ltd 2020/10/27
Lonquex Solution for Injection in Pre-filled Syringe 6mg/0.6ml842 KB
Lipegfilgrastim Drug Houses of Australia Pte Ltd 2020/09/25
Polivy Powder for Concentrate for Solution for Infusion 140mg757 KB
Polatuzumab Vedotin Roche Singapore Pte Ltd 2020/09/04 
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

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

Drug Houses of Australia Pte Ltd