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
Padcev Powder for Concentration for Solution for Infusion 20mg and 30mg509 KB Enfortumab vedotin Astellas Pharma Singapore Pte. Ltd. 2022/05/30
Vabysmo Solution for Injection 6mg/0.5ml1537 KB Faricimab Roche Singapore Pte Ltd.  2022/06/16
Tecvayli Solution for Injection 10mg/ml and 90mg/ml720 KB
 Teclistamab Johnson & Johnson International (Singapore) Pte Ltd 2024/02/16
Tezspire Solution for Injection 210MG in Pre-filled Syringe/Pre-filled Pen682 KB
 Tezepelumab AstraZeneca Singapore Pte Ltd 2023/07/04
Mektovi Film-coated Tablet 15mg2131 KB Binimetinib Zuellig Pharma Pte. Ltd.
 2023/07/19 
Braftovi Hard Capsule 50mg and 75mg2642 KB Encorafenib Zuellig Pharma Pte. Ltd. 2023/07/19 
Vocabria Film coated tablets 30mg/Prolonged-Release Suspension for Injection 600mg/3ml and 400mg/2ml1137 KB Cabotegravir GlaxoSmithKline Pte Ltd 2022/07/05
Rhopressa Opthalmic Solution 0.02%743 KB Netarsudil mesylate Santen Pharmaceutical Asia Pte Ltd 2023/07/04
Ledaga Topical Gel543 KB Chlormethine hydrochloride Juniper Biologics Pte Ltd  2024/04/15
Opdualag Concentrate for Solution for Infusion 240mg/80mg733 KB Nivolumab, Relatlimab Bristol-Myers Squibb (Singapore) Pte. Ltd. 2023/08/31
Sarclisa Concentrate for Solution for Infusion 20mg/ml649 KB Isatuxuimab Sanofi-Aventis Singapore Pte. Ltd 2022/10/13
Zeposia Capsules 0.92mg and Treatment Initiation Pack589 KB
 Ozanimod Hydrochloride Bristol-Myers Squibb (Singapore) Pte Ltd 2023/05/17
Qinlock Tablet 50mg1040 KB
 Ripretinib Specialised Therapeutics Asia Pte Ltd 2023/04/28
Spinraza Solution for Injection 12mg/5ml696 KB Nusinersen sodium Zuellig Pharma Pte. Ltd. 2023/03/31
Mounjaro Injection 2.5mg/0.5ml, 5mg/0.5ml, 7.5mg/0.5ml, 10mg/0.5ml, 12.5mg/0.5ml, 15mg/0.5ml753 KB Tirzepatide DKSH Singapore Pte Ltd 2023/02/28
Fespixon Cream 631 KB
 Centella asiatica extract, Plectranthus amboinicus extract
 Pharmeng Technology Pte Ltd 
 2023/01/31
Hibruka Tablet 50mg1017 KB
 Orelabrutinib Labcorp Development (Asia) Pte. Ltd. 2022/11/22
Jemperli Concentrate for Solution for Infusion 500mg/10ml527 KB
 Dostarlimab GlaxoSmithKline Pte Ltd 2022/10/06
Staquis Ointment 2% w/w777 KB
 Crisaborole Pfizer Private Limited 2022/09/27
Rybrevant Concentrate for Solution for Infusion 350mg/7ml498 KB
 Amivantamab Johnson & Johnson Pte. Ltd. 2022/07/13
Scemblix Film-Coated Tablet 20mg and 40mg856 KB Asciminib hydrochloride  Novartis (Singapore) Pte Ltd 2022/07/05 
Lumakras Film-coated Tablet 120mg441 KB
 Sotorasib Amgen Biotechnology Singapore Pte Ltd 2022/06/28 
Parmodia Film-Coated Tablets 0.1mg763 KB
 Pemafibrate DKSH Singapore Pte Ltd 2022/05/18
Reblozyl Powder for Solution for Injection 25 mg/vial and 75 mg/vial654 KB
 Luspatercept Bristol-Myers Squibb (Singapore) Pte Ltd 2022/04/06
Zejula Film-Coated Tablet 100mg, 200mg and 300mg826 KB
 Niraparib  GlaxoSmithKline Pte Ltd 2022/04/01 
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
Ozempic 0.25mg/dose, 0.5mg/dose, 1mg/dose Solution for Injection in Pre-filled Pen 1.34mg/ml2103 KB
 Semaglutide Novo Nordisk Pharma (Singapore) Pte Ltd 2021/04/21
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