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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
Koselugo Hard Capsules 10mg / 25mg779 KB
Selumetinib AstraZeneca Singapore Pte Ltd 2021/07/09
Mylotarg Powder for Concentrate for Solution for Infusion 5mg/vial528 KB
Gemtuzumab Ozogamicin  Pfizer Private Limited  2021/06/21
Remleas Hard Capsules 40mg794 KB Valbenazine ditosylate Mitsubishi Tanabe Pharma Singapore Pte Ltd 2021/05/19 
Replagal Concentrate for Solution for Infusion 1 mg/ml603 KB
Agalsidase Alfa
Takeda Pharmaceuticals (Asia Pacific) Pte Ltd 2021/05/17
Novoeight Powder and Solvent for Solution for Injection 250IU/vial, 500IU/vial and 1000IU/vial1022 KB
Turoctocog Alfa Novo Nordisk Pharma (Singapore) Pte Ltd 2021/03/01
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