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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
Scemblix Film-Coated Tablet 20mg and 40mg856 KB Asciminib hydrochloride  Novartis (Singapore) Pte Ltd 2022/07/05 
Zejula Film-Coated Tablet 100mg, 200mg and 300mg826 KB Niraparib GlaxoSmithKline Pte Ltd 2022/04/01
Lumakras Film-coated Tablet 120mg441 KB
Sotorasib Amgen Biotechnology Singapore Pte Ltd 2022/06/28 
Reblozyl Powder for Solution for Injection 25 mg/vial and 75 mg/vial654 KB
Luspatercept Bristol-Myers Squibb (Singapore) Pte Ltd 2022/04/06
Xpovio Film-Coated Tablet 20mg913 KB Selinexor Antengene Singapore Pte Ltd 2022/03/01 
Luconac External Solution for Nails 5%533 KB
Luliconazole Zuellig Pharma Pte Ltd 2022/02/14
Cibinqo Film-Coated Tablet 50mg, 100mg and 200mg527 KB
Abrocitinib Pfizer Private Limited 2022/01/05
Oncaspar Powder for Solution for Injection/Infusion 750 u/ml458 KB Pegaspargase Servier (S) Pte Ltd 2021/12/27
Tabrecta Film-Coated Tablet 150mg and 200mg1537 KB  Capmatinib
Novartis (Singapore) Pte Ltd 2021/10/22
Evrysdi Powder for Oral Solution 0.75 mg/ml613 KB
Risdiplam Roche Singapore Pte. Ltd. 2021/10/20
Enspryng Solution for Injection in Prefilled Syringe 120mg/1ml1802 KB

Satralizumab

Roche Singapore Pte Ltd 2021/10/19
Dayvigo Film-Coated Tablet 5mg and 10mg181 KB
Lemborexant
Eisai (Singapore) Pte Ltd 2021/09/15
Kerendia Film-Coated Tablet 10mg and 20mg887 KB Finerenone Bayer (South East Asia) Pte Ltd 2021/11/25
Tepmetko Film-Coated Tablet 225mg410 KB Tepotinib Merck Pte Ltd 2021/11/25
Verquvo Film-Coated Tablet 10mg, 5mg and 2.5mg777 KB Vericiguat Bayer (South East Asia) Pte Ltd 2021/10/01
Yupelri Inhalation Solution 175mcg/3ml2521 KB
Revefenacin Mylan Pharmaceuticals Pte. Ltd. 2021/09/28 
Enhertu Powder for Concentration for Solution for Infusion 100mg/vial1261 KB  Trastuzumab deruxtecan AstraZeneca Singapore Pte Ltd  2021/10/22
Leqvio Solution for Injection in Pre-filled Syringe 284mg/1.5ml657 KB  Inclisiran Novartis (Singapore)Pte Ltd 2021/08/03 
Vyepti Concentrate for Solution for Infusion 100mg/ml576 KB Eptinezumab Lundbeck Singapore Pte Ltd  2021/09/16 
Trodelvy Powder for Solution for Infusion 180mg/vial1516 KB
Sacituzumab govitecan Everest Medicines (Singapore) Pte Ltd 2022/01/31
Evenity Solution for Injection in Pre-filled Syringe 105mg/1.17ml1206 KB Romosozumab Amgen Biotechnology Singapore Pte Ltd 2021/05/27 
Brukinsa Capsule 80mg 575 KB
Zanubrutinib BeiGene Singapore Pte Ltd 2021/10/01
Zepzelca Powder for Solution for Infusion 4 mg/vial896 KB
Lurbinectedin Specialised Therapeutics Asia Pte Ltd 2021/09/21
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
Crysvita Solution for Injection 10 mg/ml, 20 mg/ml, 30 mg/ml1115 KB
Burosumab
Kyowa Kirin Asia Pacific Pte Ltd
2022/04/03, 2022/05/03
Eybelis Ophthalmic Solution 0.002%627 KB
Omidenepag Isopropyl Santen Pharmaceutical Asia Pte Ltd 2021/04/07
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
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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