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Archive
1 January 2025
View summary reports of therapeutic products approved from 2020-2025
For the latest approved PI, please access the Online Register of Therapeutic Products.
List of summary reports for therapeutic products approved from 2020 to 2025
Product name | Active Ingredient(s) | Product Registrant | Approval date |
|---|---|---|---|
Zerpidio Concentrate for Solution for Infusion 100mg/10ml [PDF, 8.7 MB] | Serplulimab | Innogene Kalbiotech Pte. Ltd. | 2025/05/29 |
Belzutifan | MSD Pharma (Singapore) Pte. Ltd. | 2025/05/09 | |
Vyloy powder for concentrate for solution for infusion 100mg/vial [PDF, 1 MB] | Zolbetuximab | Astellas Pharma Singapore Pte. Ltd. | 2025/03/06 |
Sunlenca Film-coated Tablet 300mg and Solution for Injection 463mg/1.5ml [PDF, 743 KB] | Lenacapavir | Gilead Sciences Singapore Pte. Ltd. | 2025/02/27 |
Loncastuxumab tesirine | Orient Europharma Pte Ltd | 2024/09/25 | |
Elrexfio Solution for Injection 44mg/1.1ml and 76mg/1.9ml [PDF, 326 KB] | Elranatamab | Pfizer Private Limited | 2024/12/31 |
Fruquintinib | Takeda Pharmaceuticals (Asia Pacific) Pte. Ltd. | 2024/10/17 | |
Talvey Solution for Injection 3mg/1.5ml and 40mg/ml [PDF, 760 KB] | Talquetamab | Johnson & Johnson International (Singapore) Pte Ltd | 2024/11/15 |
Atogepant monohydrate eqv atogepant | AbbVie Pte. Ltd. | 2024/11/29 | |
Epcoritamab | Abbvie Pte. Ltd | 2024/10/02 | |
Modified Vaccinia Ankara - Bavarian Nordic (MVA-BN,live, non-replicating) | Aenon Pharmaceuticals Sea Pte. Ltd. | 2024/08/23 | |
Spevigo Concentrate for Solution for Infusion 450mg/7.5ml [PDF, 509 KB] | Spesolimab | Boehringer Ingelheim Singapore Pte. Ltd. | 2023/10/12 |
Clascoterone | Hyphens Pharma Pte. Ltd. | 2024/08/28 | |
Imjudo Concentrate for Solution for Infusion 20mg/ml [PDF, 851 KB] | Tremelimumab | Astrazeneca Singapore Pte Ltd | 2023/08/25 |
Mavacamten | Bristol-Myers Squibb (Singapore) Pte. Ltd | 2023/06/14 | |
Amvuttra Solution for Injection in Pre-filled Syringe 25mg [PDF, 422 KB] | Vutrisiran | Medison Pharma Singapore Pte. Ltd. | 2024/10/25 |
Selpercatinib | DKSH Singapore Pte. Ltd. | 2024/04/24 | |
Ocrevus Concentrate for Solution for Infusion 300mg/10ml [PDF, 712 KB] | Ocrelizumab | Roche Singapore Pte. Ltd. | 2023/09/28 |
Pluvicto Solution for Injection/Infusion 1000 MBq/mL [PDF, 740 KB] | Lutetium (177Lu) vipivotide tetraxetan | Novartis (Singapore) Pte Ltd | 2023/12/18 |
Lunsumio Concentrate for Solution for Infusion 1mg/ml and 30mg/ml [PDF, 516 KB] | Mosunetuzumab | Roche Singapore Pte. Ltd. | 2024/05/08 |
Besremi Solution for Injection in Prefilled Syringe 500mcg/ml [PDF, 1.3 MB] | Ropeginterferon alfa-2b | Pharmaessentia Singapore Pte. Ltd. | 2024/05/29 |
Filgotinib maleate | Eisai (Singapore) Pte. Ltd. | 2024/03/27 | |
Pemigatinib | Specialised Therapeutics Asia Pte Ltd | 2024/07/09 | |
Tevimbra Concentrate for Solution for Infusion 100mg/ml [PDF, 930 KB] | Tislelizumab | Beigene Singapore Pte. Ltd. | 2024/09/19 |
Trecondi Powder for Solution for Infusion 1g and 5g [PDF, 533 KB] | Treosulfan | Link Healthcare Singapore Pte Ltd | 2023/12/26 |
Columvi Concentrate for Solution for Infusion 1mg/ml [PDF, 571 KB] | Glofitamab | Roche Singapore Pte. Ltd. | 2024/03/05 |
Padcev Powder for Concentration for Solution for Infusion 20mg and 30mg [PDF, 509 KB] | Enfortumab vedotin | Astellas Pharma Singapore Pte. Ltd. | 2022/05/30 |
Faricimab | Roche Singapore Pte Ltd. | 2022/06/16 | |
Tecvayli Solution for Injection 10mg/ml and 90mg/ml [PDF, 720 KB] | Teclistamab | Johnson & Johnson International (Singapore) Pte Ltd | 2024/02/16 |
Tezspire Solution for Injection 210MG in Pre-filled Syringe/Pre-filled Pen [PDF, 682 KB] | Tezepelumab | AstraZeneca Singapore Pte Ltd | 2023/07/04 |
Binimetinib | Zuellig Pharma Pte. Ltd. | 2023/07/19 | |
Encorafenib | Zuellig Pharma Pte. Ltd. | 2023/07/19 | |
Cabotegravir | GlaxoSmithKline Pte Ltd | 2022/07/05 | |
Netarsudil mesylate | Santen Pharmaceutical Asia Pte Ltd | 2023/07/04 | |
Chlormethine hydrochloride | Juniper Biologics Pte Ltd | 2024/04/15 | |
Opdualag Concentrate for Solution for Infusion 240mg/80mg [PDF, 733 KB] | Nivolumab, Relatlimab | Bristol-Myers Squibb (Singapore) Pte. Ltd. | 2023/08/31 |
Sarclisa Concentrate for Solution for Infusion 20mg/ml [PDF, 649 KB] | Isatuxuimab | Sanofi-Aventis Singapore Pte. Ltd | 2022/10/13 |
Zeposia Capsules 0.92mg and Treatment Initiation Pack [PDF, 589 KB] | Ozanimod Hydrochloride | Bristol-Myers Squibb (Singapore) Pte Ltd | 2023/05/17 |
Ripretinib | Specialised Therapeutics Asia Pte Ltd | 2023/04/28 | |
Nusinersen sodium | Zuellig Pharma Pte. Ltd. | 2023/03/31 | |
Tirzepatide | DKSH Singapore Pte Ltd | 2023/02/28 | |
Centella asiatica extract, Plectranthus amboinicus extract | Pharmeng Technology Pte Ltd | 2023/01/31 | |
Orelabrutinib | Labcorp Development (Asia) Pte. Ltd. | 2022/11/22 | |
Jemperli Concentrate for Solution for Infusion 500mg/10ml [PDF, 527 KB] | Dostarlimab | GlaxoSmithKline Pte Ltd | 2022/10/06 |
Crisaborole | Pfizer Private Limited | 2022/09/27 | |
Rybrevant Concentrate for Solution for Infusion 350mg/7ml [PDF, 498 KB] | Amivantamab | Johnson & Johnson Pte. Ltd. | 2022/07/13 |
Asciminib hydrochloride | Novartis (Singapore) Pte Ltd | 2022/07/05 | |
Sotorasib | Amgen Biotechnology Singapore Pte Ltd | 2022/06/28 | |
Pemafibrate | DKSH Singapore Pte Ltd | 2022/05/18 | |
Reblozyl Powder for Solution for Injection 25 mg/vial and 75 mg/vial [PDF, 654 KB] | Luspatercept | Bristol-Myers Squibb (Singapore) Pte Ltd | 2022/04/06 |
Zejula Film-Coated Tablet 100mg, 200mg and 300mg [PDF, 826 KB] | Niraparib | GlaxoSmithKline Pte Ltd | 2022/04/01 |
Selinexor | Antengene Singapore Pte Ltd | 2022/03/01 | |
Luliconazole | Zuellig Pharma Pte Ltd | 2022/02/14 | |
Cibinqo Film-Coated Tablet 50mg, 100mg and 200mg [PDF, 527 KB] | Abrocitinib | Pfizer Private Limited | 2022/01/05 |
Oncaspar Powder for Solution for Injection/Infusion 750 u/ml [PDF, 458 KB] | Pegaspargase | Servier (S) Pte Ltd | 2021/12/27 |
Capmatinib | Novartis (Singapore) Pte Ltd | 2021/10/22 | |
Risdiplam | Roche Singapore Pte. Ltd. | 2021/10/20 | |
Enspryng Solution for Injection in Prefilled Syringe 120mg/1ml [PDF, 1.8 MB] | Satralizumab | Roche Singapore Pte Ltd | 2021/10/19 |
Lemborexant | Eisai (Singapore) Pte Ltd | 2021/09/15 | |
Finerenone | Bayer (South East Asia) Pte Ltd | 2021/11/25 | |
Tepotinib | Merck Pte Ltd | 2021/11/25 | |
Verquvo Film-Coated Tablet 10mg, 5mg and 2.5mg [PDF, 777 KB] | Vericiguat | Bayer (South East Asia) Pte Ltd | 2021/10/01 |
Revefenacin | Mylan Pharmaceuticals Pte. Ltd. | 2021/09/28 | |
Enhertu Powder for Concentration for Solution for Infusion 100mg/vial [PDF, 1.2 MB] | Trastuzumab deruxtecan | AstraZeneca Singapore Pte Ltd | 2021/10/22 |
Leqvio Solution for Injection in Pre-filled Syringe 284mg/1.5ml [PDF, 657 KB] | Inclisiran | Novartis (Singapore)Pte Ltd | 2021/08/03 |
Vyepti Concentrate for Solution for Infusion 100mg/ml [PDF, 576 KB] | Eptinezumab | Lundbeck Singapore Pte Ltd | 2021/09/16 |
Trodelvy Powder for Solution for Infusion 180mg/vial [PDF, 1.5 MB] | Sacituzumab govitecan | Everest Medicines (Singapore) Pte Ltd | 2022/01/31 |
Evenity Solution for Injection in Pre-filled Syringe 105mg/1.17ml [PDF, 1.2 MB] | Romosozumab | Amgen Biotechnology Singapore Pte Ltd | 2021/05/27 |
Zanubrutinib | BeiGene Singapore Pte Ltd | 2021/10/01 | |
Zepzelca Powder for Solution for Infusion 4 mg/vial [PDF, 896 KB] | Lurbinectedin | Specialised Therapeutics Asia Pte Ltd | 2021/09/21 |
Selumetinib | AstraZeneca Singapore Pte Ltd | 2021/07/09 | |
Mylotarg Powder for Concentrate for Solution for Infusion 5mg/vial [PDF, 528 KB] | Gemtuzumab Ozogamicin | Pfizer Private Limited | 2021/06/21 |
Valbenazine ditosylate | Mitsubishi Tanabe Pharma Singapore Pte Ltd | 2021/05/19 | |
Replagal Concentrate for Solution for Infusion 1 mg/ml [PDF, 603 KB] | Agalsidase Alfa | Takeda Pharmaceuticals (Asia Pacific) Pte Ltd | 2021/05/17 |
Crysvita Solution for Injection 10 mg/ml, 20 mg/ml, 30 mg/ml [PDF, 1.1 MB] | Burosumab | Kyowa Kirin Asia Pacific Pte Ltd | 2022/04/03, 2022/05/03 |
Semaglutide | Novo Nordisk Pharma (Singapore) Pte Ltd | 2021/04/21 | |
Omidenepag Isopropyl | Santen Pharmaceutical Asia Pte Ltd | 2021/04/07 | |
Turoctocog Alfa | Novo Nordisk Pharma (Singapore) Pte Ltd | 2021/03/01 | |
Vpriv Powder for Solution for Infusion 400units/vial [PDF, 483 KB] | Velaglucerase alfa | Takeda Pharmaceuticals (Asia Pacific) Pte Ltd | 2021/02/24 |
Ofatumumab | Novartis (Singapore) Pte Ltd | 2021/02/05 | |
Entrectinib | Roche Singapore Pte Ltd | 2021/01/27 | |
Shingrix Powder and Suspension for Suspension for Injection 50 mcg/ 0.5 ml [PDF, 444 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/vial [PDF, 411 KB] | Perfluorobutane (microbubbles) | GE Healthcare | 2021/01/06 |
Lixiana Film-Coated Tablets 15mg, 30mg and 60mg [PDF, 677 KB] | Edoxaban Tosilate | A. Menarini Singapore Pte Ltd | 2020/12/18 |
Dinalbuphine sebacate | Intega Pte Ltd | 2020/12/15 | |
Rurioctocog alfa pegol | Takeda Pharmaceuticals | 2020/11/24 | |
Esketamine | Johnson & Johnson Pte Ltd | 2020/10/27 | |
Lonquex Solution for Injection in Pre-filled Syringe 6mg/0.6ml [PDF, 842 KB] | Lipegfilgrastim | Drug Houses of Australia Pte Ltd | 2020/09/25 |
Polivy Powder for Concentrate for Solution for Infusion 140mg [PDF, 757 KB] | Polatuzumab Vedotin | Roche Singapore Pte Ltd | 2020/09/04 |
Vitrakvi Hard Capsules 25mg and 100mg, Oral Solution 20mg/ml [PDF, 573 KB] | Larotrectinib | Bayer (South East Asia) Pte Ltd | 2020/08/17 |
Erdafitinib | Johnson & Johnson Pte Ltd | 2020/08/07 | |
Skyrizi Solution For Injection in Pre-Filled Syringe 75mg [PDF, 428 KB] | Risankizumab | Abbvie Pte Ltd | 2020/07/06 |
Vizimpro Film Coated Tablet 15mg, 30mg and 45mg [PDF, 638 KB] | Dacomitinib Monohydrate | Pfizer Private Limited | 2020/06/25 |
Sodium Zirconium Cyclosilicate | AstraZeneca Singapore Pte Ltd | 2020/06/22 | |
Veklury Lyophilized Powder for IV Infusion 100mg and Solution for IV Infusion 5mg/ml [PDF, 96 KB] | Remdesivir | Gilead Sciences Singapore Pte Ltd | 2020/06/10 |
Lutetium (177Lu) oxodotreotide | Novartis (Singapore) Pte Ltd | 2020/06/01 | |
Talazoparib tosylate | Pfizer Private Limited | 2020/05/20 | |
Tukysa Film-Coated Tablets 50mg and 150mg [PDF, 1 MB] *Evaluated as part of Project Orbis | Tucatinib | Nyprax Pharma Pte Ltd | 2020/05/19 |
Ajovy Solution for Injection in Pre-filled Syringe 225mg/1.5ml [PDF, 552 KB] | Fremanezumab | Drug Houses of Australia Pte Ltd | 2020/05/08 |