Listing of approvals

Product Name

Product Information

LUMAKRAS FILM-COATED TABLET 240MG
(SIN17527P)

Active Ingredient(s): Sotorasib(240mg)

Application Type: NDA-3

Product Registrant: AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Approval Date: 28/04/2026

VERDYE POWDER FOR SOLUTION FOR INJECTION 25 MG/VIAL
(SIN17525P)

Active Ingredient(s): Indocyanine Green(25 mg/vial)

Application Type: NDA-1

Product Registrant: TRANSMEDIC PTE LTD

Approval Date: 27/04/2026

FIRAZYR SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 30MG/3ML
(SIN17516P)

Active Ingredient(s): Icatibant acetate eqv icatibant(30 mg/3mL)

Application Type: NDA-1

Product Registrant: TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Approval Date: 15/04/2026

CREON 25000 CAPSULE, COATED PELLETS 300MG
(SIN17515P)

Active Ingredient(s): PANCREAS POWDER(300mg)

Application Type: NDA-3

Product Registrant: ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

Approval Date: 10/04/2026

TAKHZYRO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 150MG/ML
(SIN17510P)

Active Ingredient(s): Lanadelumab(150mg/mL)

Application Type: NDA-2

Product Registrant: TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Approval Date: 01/04/2026

TAKHZYRO SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 300MG/2ML
(SIN17511P)

Active Ingredient(s): Lanadelumab(300mg/2mL)

Application Type: NDA-1

Product Registrant: TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Approval Date: 01/04/2026

STREPSILS MAX PRO DIRECT SPRAY HONEY AND LEMON 8.75MG PER DOSE
(SIN17495P)

Active Ingredient(s): Flurbiprofen(8.748mg/dose)

Application Type: NDA-2

Product Registrant: RECKITT BENCKISER (SINGAPORE) PTE LTD

Approval Date: 24/03/2026

DIFFLAM PLUS ANAESTHETIC SORE THROAT SPRAY
(SIN17493P)

Active Ingredient(s): 2,4 Dichlorobenzyl alcohol(338 mcg/spray),Benzydamine hydrochloride(390 mcg/spray),Lidocaine hydrochloride monohydrate(559 mcg/spray)

Application Type: NDA-2

Product Registrant: INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Approval Date: 23/03/2026

TANSTRIVE TABLETS 80MG
(SIN17488P)

Active Ingredient(s): Selpercatinib(80mg)

Application Type: NDA-3

Product Registrant: DKSH SINGAPORE PTE. LTD.

Approval Date: 19/03/2026

TANSTRIVE TABLETS 40MG
(SIN17487P)

Active Ingredient(s): Selpercatinib(40mg)

Application Type: NDA-2

Product Registrant: DKSH SINGAPORE PTE. LTD.

Approval Date: 19/03/2026

EVRYSDI FILM-COATED TABLET 5MG
(SIN17484P)

Active Ingredient(s): Risdiplam(5.000 mg)

Application Type: NDA-2

Product Registrant: ROCHE SINGAPORE PTE. LTD.

Approval Date: 16/03/2026

TIBSOVO FILM-COATED TABLET 250MG
(SIN17485P)

Active Ingredient(s): Ivosidenib(250.0mg)

Application Type: NDA-1

Product Registrant: SERVIER (S) PTE LTD

Approval Date: 16/03/2026

MRESVIA DISPERSION FOR INJECTION IN PRE-FILLED SYRINGE 50MCG/0.5ML
(SIN17482P)

Active Ingredient(s): RNA-100-AR02 (mRNA-1345 encoding RSV F glycoprotein in prefusion conformation)(0.050mg/0.5ml dose)

Application Type: NDA-1

Product Registrant: MODERNA BIOTECH SINGAPORE PTE. LTD.

Approval Date: 06/03/2026

CAPVAXIVE SOLUTION FOR INJECTION
(SIN17471P)

Active Ingredient(s): (MBC) Pneumococcal Polysaccharide Serotype 10A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 11A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 12F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 15A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 16F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 17F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 19A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 20A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 22F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 23A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 23B conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 24F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 3 conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 31 conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 33F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 35B conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 6A conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 7F conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 8 conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide Serotype 9N conjugated to CRM197(4ug/0.5mL),(MBC) Pneumococcal Polysaccharide de-O-acetylated Serotype 15B conjugated to CRM197(4ug/0.5mL)

Application Type: NDA-1

Product Registrant: MSD PHARMA (SINGAPORE) PTE. LTD.

Approval Date: 20/02/2026

FLUARIX SUSPENSION FOR INJECTION
(SIN17468P)

Active Ingredient(s): Influenza Virus (NH) A/Thailand/8/2022 (H3N2)-like strain(15 μg Haemagglutinin/ 0.5 mL),Influenza Virus (NH) A/Victoria/4897/2022 (H1N1)pdm09-like strain(15 μg Haemagglutinin/ 0.5 mL),Influenza Virus (NH) B/Austria/1359417/2021-like strain(15 μg Haemagglutinin/ 0.5 mL)

Application Type: NDA-2

Product Registrant: GLAXOSMITHKLINE PTE LTD

Approval Date: 13/02/2026

ENFLONSIA™ SOLUTION FOR INJECTION 105MG/0.7ML IN PRE-FILLED SYRINGE
(SIN17467P)

* Evaluated via Access

Active Ingredient(s): Clesrovimab(105mg/0.7mL)

Application Type: NDA-1

Product Registrant: MSD PHARMA (SINGAPORE) PTE. LTD.

Approval Date: 12/02/2026

ADACEL, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE 0.5 ML
(SIN17460P)

Active Ingredient(s): (Acellular Pertussis) FilamentousHaemagglutinin Adsorbed (FHA)(5 μg/ 0.5mL),(Acellular Pertussis) Fimbriae Type 2 and 3Adsorbed (FIM)(5 μg/ 0.5mL),(Acellular Pertussis) Pertactin Adsorbed (PRN)(3 μg/ 0.5mL),(Acelullar Pertussis) Pertussis ToxoidAdsorbed (PT)(2.5 μg/ 0.5mL),Diphtheria Toxoid Adsorbed(2 LF/ 0.5mL),Tetanus Toxoid Adsorbed(5 LF/ 0.5mL)

Application Type: NDA-2

Product Registrant: SANOFI-AVENTIS SINGAPORE PTE. LTD.

Approval Date: 09/02/2026

EMBLAVEO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1.5G/0.5G
(SIN17438P)

* Evaluated via ASEAN Joint review

Active Ingredient(s): Avibactam Sodium eqv Avibactam(0.5 g/vial ),Aztreonam(1.5 g/vial)

Application Type: NDA-2

Product Registrant: PFIZER PRIVATE LIMITED

Approval Date: 15/01/2026

JUBBONTI SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 60MG/ML
(SIN17439P)

Active Ingredient(s): Denosumab(60 mg/ml)

Application Type: NDA-2: Biosimilar

Product Registrant: SANDOZ SINGAPORE PTE. LTD.

Approval Date: 15/01/2026

WYOST SOLUTION FOR INJECTION 120MG/1.7ML
(SIN17440P)

Active Ingredient(s): Denosumab(120 mg/1.7ml)

Application Type: NDA-2: Biosimilar

Product Registrant: SANDOZ SINGAPORE PTE. LTD.

Approval Date: 15/01/2026

VALTOCO NASAL SPRAY 10MG/SPRAY
(SIN17435P)

Active Ingredient(s): Diazepam(10mg/spray)

Application Type: NDA-2

Product Registrant: RXILIENT MEDICAL PTE LTD

Approval Date: 14/01/2026

VALTOCO NASAL SPRAY 5MG/SPRAY
(SIN17437P)

Active Ingredient(s): Diazepam(5.00mg/spray)

Application Type: NDA-3

Product Registrant: RXILIENT MEDICAL PTE LTD

Approval Date: 14/01/2026

VALTOCO NASAL SPRAY 7.5MG/SPRAY
(SIN17436P)

Active Ingredient(s): Diazepam(7.5mg/ spray)

Application Type: NDA-3

Product Registrant: RXILIENT MEDICAL PTE LTD

Approval Date: 14/01/2026

FRAGMIN SOLUTION FOR INJECTION PREFILLED SYRINGE 2500 IU/0.2 ML
(SIN17433P)

Active Ingredient(s): Dalteparin Sodium(2500 IU/0.2ml)

Application Type: NDA-2

Product Registrant: PFIZER PRIVATE LIMITED

Approval Date: 13/01/2026

FRAGMIN SOLUTION FOR INJECTION PREFILLED SYRINGE 5000 IU/0.2 ML
(SIN17434P)

Active Ingredient(s): Dalteparin Sodium(5000 IU/0.2ml)

Application Type: NDA-3

Product Registrant: PFIZER PRIVATE LIMITED

Approval Date: 13/01/2026

PAXLOVID (NIRMATRELVIR AND RITONAVIR) FILM-COATED TABLETS
(SIN17428P)

Active Ingredient(s): Nirmatrelvir(150 mg),Ritonavir(100 mg)

Application Type: NDA-2

Product Registrant: PFIZER PRIVATE LIMITED

Approval Date: 07/01/2026

Product Name

Product Information

SITANISH-100 SITAGLIPTIN FILM-COATED TABLET 100MG
(SIN17526P)

Active Ingredient(s): Sitagliptin Phosphate Monohydrate eqv Sitagliptin(100mg)

Application Type: GDA-1

Product Registrant: ALMA-A PTE LTD

Approval Date: 28/04/2026

VELSONE FILM COATED TABLETS 800MG
(SIN17524P)

Active Ingredient(s): Sevelamer Carbonate(800 mg)

Application Type: GDA-1

Product Registrant: SEA PHARMA CONSULTANCY PTE LTD

Approval Date: 27/04/2026

STRINEORA 100 - CYCLOSPORINE CAPSULES USP 100MG
(SIN17521P)

Active Ingredient(s): Cyclosporine(100 mg)

Application Type: GDA-1

Product Registrant: STRIDES PHARMA GLOBAL PTE. LIMITED

Approval Date: 23/04/2026

STRINEORA 50 - CYCLOSPORINE CAPSULES USP 50MG
(SIN17522P)

Active Ingredient(s): Cyclosporine(50 mg)

Application Type: GDA-2

Product Registrant: STRIDES PHARMA GLOBAL PTE. LIMITED

Approval Date: 23/04/2026

STRINEORA 25- CYCLOSPORINE CAPSULES USP 25MG
(SIN17523P)

Active Ingredient(s): Cyclosporine(25 mg)

Application Type: GDA-2

Product Registrant: STRIDES PHARMA GLOBAL PTE. LIMITED

Approval Date: 23/04/2026

CLOBAZEN TABLETS 10MG
(SIN17520P)

Active Ingredient(s): Clobazam(10 mg)

Application Type: GDA-1

Product Registrant: PHARMAZEN MEDICALS PTE LTD

Approval Date: 21/04/2026

JAMP EPLERENONE TABLETS 50MG
(SIN17518P)

Active Ingredient(s): Eplerenone(50mg)

Application Type: GDA-1

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 21/04/2026

JAMP EPLERENONE TABLETS 25MG
(SIN17519P)

Active Ingredient(s): Eplerenone(25mg)

Application Type: GDA-2

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 21/04/2026

ALLUTAMIDE SOFT CAPSULES 40MG
(SIN17517P)

Active Ingredient(s): Enzalutamide(40 mg)

Application Type: GDA-1

Product Registrant: LOTUS INTERNATIONAL PTE. LTD.

Approval Date: 16/04/2026

NEVOLET 5 NEBIVOLOL TABLETS 5 MG
(SIN17514P)

Active Ingredient(s): Nebivolol Hydrochloride equivalent to Nebivolol(5.000 mg)

Application Type: GDA-1

Product Registrant: HETERO SINGAPORE PTE. LTD.

Approval Date: 10/04/2026

ENZALUDEZ SOFT CAPSULE 40MG
(SIN17513P)

Active Ingredient(s): Enzalutamide(40.000 mg)

Application Type: GDA-1

Product Registrant: SANDOZ SINGAPORE PTE. LTD.

Approval Date: 08/04/2026

SUGAMMADEX BAXTER SOLUTION FOR INJECTION 100 MG/ML
(SIN17512P)

Active Ingredient(s): Sugammadex sodium equivalent to Sugammadex(100 mg/mL)

Application Type: GDA-1

Product Registrant: BAXTER HEALTHCARE (ASIA) PTE LTD

Approval Date: 04/04/2026

AVEXA AVILDAG TABLET 50MG
(SIN17509P)

Active Ingredient(s): Vildagliptin(50.000 mg)

Application Type: GDA-1

Product Registrant: APEX PHARMA MARKETING PTE. LTD.

Approval Date: 01/04/2026

ANICURA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG
(SIN17508P)

Active Ingredient(s): Anidulafungin(100 mg)

Application Type: GDA-1

Product Registrant: INTEGA PTE LTD

Approval Date: 30/03/2026

XABAREM FILM-COATED TABLETS 20 MG
(SIN17504P)

Active Ingredient(s): Rivaroxaban(20 mg)

Application Type: GDA-1

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 27/03/2026

XABAREM FILM-COATED TABLETS 15 MG
(SIN17505P)

Active Ingredient(s): Rivaroxaban(15 mg)

Application Type: GDA-2

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 27/03/2026

XABAREM FILM-COATED TABLETS 10 MG
(SIN17506P)

Active Ingredient(s): Rivaroxaban(10 mg)

Application Type: GDA-2

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 27/03/2026

XABAREM FILM-COATED TABLETS 2.5 MG
(SIN17507P)

Active Ingredient(s): Rivaroxaban(2.5 mg )

Application Type: GDA-2

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 27/03/2026

XYLOCREAM 5% W/W
(SIN17501P)

Active Ingredient(s): Lidocaine(2.5 % w/w),Prilocaine(2.5 % w/w)

Application Type: GDA-1

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 26/03/2026

BENDAMUSTINE HYDROCHLORIDE ADVAGEN POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/VIAL
(SIN17503P)

Active Ingredient(s): Bendamustine Hydrochloride Monohydrate equivalent to Bendamustine Hydrochloride(100 mg/vial)

Application Type: GDA-2

Product Registrant: ADVAGEN PTE. LTD.

Approval Date: 26/03/2026

BENDAMUSTINE HYDROCHLORIDE ADVAGEN POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 25 MG/VIAL
(SIN17502P)

Active Ingredient(s): Bendamustine Hydrochloride Monohydrate equivalent to Bendamustine Hydrochloride(25 mg/vial)

Application Type: GDA-1

Product Registrant: ADVAGEN PTE. LTD.

Approval Date: 26/03/2026

ATSWIFT-EZ FILM COATED TABLETS 80MG/10MG
(SIN17496P)

Active Ingredient(s): Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(80 mg ),Ezetimibe(10 mg )

Application Type: GDA-1

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 25/03/2026

DYDROGESTERONE INTEGA FILM COATED TABLET 10MG
(SIN17500P)

Active Ingredient(s): Dydrogesterone(10.00 mg)

Application Type: GDA-1

Product Registrant: INTEGA PTE LTD

Approval Date: 25/03/2026

ATSWIFT-EZ FILM COATED TABLETS 40MG/10MG
(SIN17497P)

Active Ingredient(s): Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(40 mg ),Ezetimibe(10 mg )

Application Type: GDA-2

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 25/03/2026

ATSWIFT-EZ FILM COATED TABLETS 20MG/10MG
(SIN17498P)

Active Ingredient(s): Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(20 mg ),Ezetimibe(10 mg )

Application Type: GDA-2

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 25/03/2026

ATSWIFT-EZ FILM COATED TABLETS 10MG/10MG
(SIN17499P)

Active Ingredient(s): Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(10 mg ),Ezetimibe(10 mg )

Application Type: GDA-2

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 25/03/2026

DURO-TUSS DM DRY COUGH LIQUID 15MG/5ML
(SIN17494P)

Active Ingredient(s): Dextromethorphan hydrobromide eqv. Dextromethorphan(15mg/5mL)

Application Type: GDA-1

Product Registrant: INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Approval Date: 24/03/2026

MELIFORT EXTENDED RELEASE TABLET 500MG
(SIN17492P)

Active Ingredient(s): Metformin Hydrochloride(500mg)

Application Type: GDA-2

Product Registrant: APEX PHARMA MARKETING PTE. LTD.

Approval Date: 23/03/2026

MELIFORT EXTENDED RELEASE TABLET 750MG
(SIN17491P)

Active Ingredient(s): Metformin Hydrochloride(750mg)

Application Type: GDA-2

Product Registrant: APEX PHARMA MARKETING PTE. LTD.

Approval Date: 23/03/2026

MELIFORT EXTENDED RELEASE TABLET 1000MG
(SIN17490P)

Active Ingredient(s): Metformin Hydrochloride(1000mg)

Application Type: GDA-1

Product Registrant: APEX PHARMA MARKETING PTE. LTD.

Approval Date: 23/03/2026

AMOKLAVIN-BID FILM COATED TABLETS 1000 MG
(SIN17489P)

Active Ingredient(s): Amoxicillin Trihydrate eqv Amoxicillin(875 mg ),Potassium Clavulanate eqv Clavulanic Acid(125 mg)

Application Type: GDA-1

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 20/03/2026

AIRKEFAY FILM-COATED TABLETS 200MG
(SIN17486P)

Active Ingredient(s): Sorafenib Tosylate eqv Sorafenib(200mg)

Application Type: GDA-1

Product Registrant: KEXING BIOPHARMA SINGAPORE PTE. LTD.

Approval Date: 19/03/2026

MEGVAL™ POWDER FOR SOLUTION FOR INJECTION 50MG/VIAL
(SIN17483P)

Active Ingredient(s): Melphalan Hydrochloride eqv Melphalan(50 mg/vial)

Application Type: GDA-1

Product Registrant: ADVAGEN PTE. LTD.

Approval Date: 10/03/2026

RESPIRO AEROSOL INHALER 25MCG/250MCG PER DOSE
(SIN17479P)

Active Ingredient(s): Fluticasone propionate(250 mcg/dose),Salmeterol xinafoate equivalent to salmeterol(25 mcg/dose)

Application Type: GDA-1

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 04/03/2026

RHINOLONE NASAL SPRAY 55 MICROGRAMS/DOSE
(SIN17481P)

Active Ingredient(s): Triamcinolone acetonide(55 mcg/dose)

Application Type: GDA-1

Product Registrant: NOVEM HEALTHCARE PTE LTD

Approval Date: 04/03/2026

RESPIRO AEROSOL INHALER 25 MCG/125 MCG PER DOSE
(SIN17480P)

Active Ingredient(s): Fluticasone propionate(125 mcg/dose),Salmeterol xinafoate equivalent to salmeterol(25 mcg/dose)

Application Type: GDA-2

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 04/03/2026

INSTADIP 100 FILM COATED TABLET USP 100 MG
(SIN17478P)

Active Ingredient(s): Sitagliptin Phosphate eq to Sitagliptin(100 mg)

Application Type: GDA-1

Product Registrant: RANBAXY (MALAYSIA) SDN. BHD.

Approval Date: 03/03/2026

INSTADIP 25 FILM COATED TABLET USP 25MG
(SIN17477P)

Active Ingredient(s): Sitagliptin Phosphate eq to Sitagliptin(25 mg)

Application Type: GDA-2

Product Registrant: RANBAXY (MALAYSIA) SDN. BHD.

Approval Date: 03/03/2026

INSTADIP 50 FILM COATED TABLET USP 50MG
(SIN17476P)

Active Ingredient(s): Sitagliptin Phosphate eq to Sitagliptin(50 mg)

Application Type: GDA-2

Product Registrant: RANBAXY (MALAYSIA) SDN. BHD.

Approval Date: 03/03/2026

OLANZAPINE-TEVA FC TABLET 10MG
(SIN17474P)

Active Ingredient(s): Olanzapine(10 mg)

Application Type: GDA-1

Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Approval Date: 27/02/2026

DREXRED 500 LEVETIRACETAM FILM-COATED TABLETS 500 MG
(SIN17475P)

Active Ingredient(s): LEVETIRACETAM(500.00 MG)

Application Type: GDA-1

Product Registrant: ZYFAS PHARMA PTE LTD

Approval Date: 27/02/2026

OLANZAPINE-TEVA FC TABLET 5MG
(SIN17473P)

Active Ingredient(s): Olanzapine(5 mg)

Application Type: GDA-2

Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Approval Date: 27/02/2026

DR. REDDY'S ATORVASTATIN FILM COATED TABLET 40MG USP
(SIN17472P)

Active Ingredient(s): Atorvastatin Calcium Trihydrate (Form 1) equivalent to atorvastatin(40mg)

Application Type: GDA-2

Product Registrant: ZYFAS PHARMA PTE LTD

Approval Date: 24/02/2026

TACHYBAN (ADENOSINE INJECTION USP) 3MG/ML
(SIN17470P)

Active Ingredient(s): Adenosine(3mg/ml)

Application Type: GDA-1

Product Registrant: SIXMURS SINGAPORE PTE. LTD.

Approval Date: 16/02/2026

DAFASGLIT 10 FILM-COATED TABLETS 10MG
(SIN17469P)

Active Ingredient(s): Dapagliflozin(10.000 mg)

Application Type: GDA-1

Product Registrant: APOTHECA MARKETING PTE LTD

Approval Date: 14/02/2026

ROST 20 ROSUVASTATIN TABLETS 20 MG
(SIN17466P)

Active Ingredient(s): Rosuvastatin Calcium equivalent to Rosuvastatin(20.000 mg)

Application Type: GDA-1

Product Registrant: HETERO SINGAPORE PTE. LTD.

Approval Date: 11/02/2026

ROST 10 ROSUVASTATIN TABLETS 10 MG
(SIN17465P)

Active Ingredient(s): Rosuvastatin Calcium equivalent to Rosuvastatin(10.000 mg)

Application Type: GDA-2

Product Registrant: HETERO SINGAPORE PTE. LTD.

Approval Date: 11/02/2026

ZYROXABAN FILM COATED TABLET 15MG
(SIN17462P)

Active Ingredient(s): Rivaroxaban (micronised)(15mg)

Application Type: GDA-2

Product Registrant: APEX PHARMA MARKETING PTE. LTD.

Approval Date: 10/02/2026

ZYROXABAN FILM COATED TABLET 10MG
(SIN17463P)

Active Ingredient(s): RIVAROXABAN (MICRONISED)(10MG)

Application Type: GDA-2

Product Registrant: APEX PHARMA MARKETING PTE. LTD.

Approval Date: 10/02/2026

ZYROXABAN FILM COATED TABLET 20MG
(SIN17461P)

Active Ingredient(s): Rivaroxaban (micronised)(20mg)

Application Type: GDA-1

Product Registrant: APEX PHARMA MARKETING PTE. LTD.

Approval Date: 10/02/2026

OBITOCIN SOLUTION FOR INJECTION IN PREFILLED SYRINGE 100MCG/ML
(SIN17464P)

Active Ingredient(s): Carbetocin(100 mcg/ml)

Application Type: GDA-1

Product Registrant: UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

Approval Date: 10/02/2026

ESOMEPRAZOLE AUXILTO GASTRO-RESISTANT TABLETS 20MG
(SIN17455P)

Active Ingredient(s): Esomeprazole Magnesium Trihydrate eqv. Esomeprazole(20mg)

Application Type: GDA-2

Product Registrant: AUXILTO IMPEX PTE. LTD.

Approval Date: 09/02/2026

TORVASTATIN FC TABLET 80MG
(SIN17456P)

Active Ingredient(s): Atorvastatin Calcium eqv to Atorvastatin(80mg)

Application Type: GDA-1

Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Approval Date: 09/02/2026

ESOMEPRAZOLE AUXILTO GASTRO-RESISTANT TABLETS 40MG
(SIN17454P)

Active Ingredient(s): Esomeprazole Magnesium Trihydrate eqv. Esomeprazole(40mg)

Application Type: GDA-1

Product Registrant: AUXILTO IMPEX PTE. LTD.

Approval Date: 09/02/2026

TORVASTATIN FC TABLET 10MG
(SIN17459P)

Active Ingredient(s): Atorvastatin Calcium eqv to Atorvastatin(10mg)

Application Type: GDA-2

Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Approval Date: 09/02/2026

TORVASTATIN FC TABLET 20MG
(SIN17458P)

Active Ingredient(s): Atorvastatin Calcium eqv to Atorvastatin(20mg)

Application Type: GDA-2

Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Approval Date: 09/02/2026

TORVASTATIN FC TABLET 40MG
(SIN17457P)

Active Ingredient(s): Atorvastatin Calcium eqv to Atorvastatin(40mg)

Application Type: GDA-2

Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Approval Date: 09/02/2026

NOREPINEPHRINE SCIGEN CONCENTRATE FOR SOLUTION FOR INFUSION 4 MG/4ML
(SIN17453P)

Active Ingredient(s): Norepinephrine Bitartrate eqv. Norephinephrine(4mg/4ml)

Application Type: GDA-1

Product Registrant: SCIGEN PTE. LTD.

Approval Date: 04/02/2026

TRANEXAMIC ACID MEVON FILM-COATED TABLETS 500 MG
(SIN17452P)

Active Ingredient(s): Tranexamic acid(500.00 mg)

Application Type: GDA-1

Product Registrant: NOVEM HEALTHCARE PTE LTD

Approval Date: 03/02/2026

RIVAROXABAN-TEVA FC TABLET 2.5MG
(SIN17451P)

Active Ingredient(s): Rivaroxaban(2.5 mg)

Application Type: GDA-2

Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Approval Date: 02/02/2026

RIVAROXABAN-TEVA FC TABLET 20MG
(SIN17448P)

Active Ingredient(s): Rivaroxaban(20 mg)

Application Type: GDA-1

Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Approval Date: 02/02/2026

RIVAROXABAN-TEVA FC TABLET 10MG
(SIN17450P)

Active Ingredient(s): Rivaroxaban(10 mg)

Application Type: GDA-2

Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Approval Date: 02/02/2026

RIVAROXABAN-TEVA FC TABLET 15MG
(SIN17449P)

Active Ingredient(s): Rivaroxaban(15 mg)

Application Type: GDA-2

Product Registrant: TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

Approval Date: 02/02/2026

PHENASEN CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/10ML
(SIN17447P)

Active Ingredient(s): Arsenic Trioxide(10mg/10ml)

Application Type: GDA-1

Product Registrant: PHEBRA (SE ASIA) PTE. LTD.

Approval Date: 29/01/2026

MOXICLAV POWDER FOR SOLUTION FOR INJECTION/ INFUSION 1.2G/VIAL
(SIN17446P)

Active Ingredient(s): Amoxicillin sodium eqv. to Amoxicillin(1000mg/vial),Potassium clavulanate eqv. to Clavulanic acid(200mg/vial)

Application Type: GDA-1

Product Registrant: MEDOCHEMIE SINGAPORE PTE. LTD.

Approval Date: 27/01/2026

JAMP-CHOLESTYRAMINE POWDER FOR ORAL SUSPENSION 4G
(SIN17445P)

Active Ingredient(s): Cholestyramine resin(4000mg)

Application Type: GDA-1

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 23/01/2026

ZYGABALIN HARD CAPSULE 50MG
(SIN17444P)

Active Ingredient(s): Pregabalin(50mg)

Application Type: GDA-2

Product Registrant: APEX PHARMA MARKETING PTE. LTD.

Approval Date: 22/01/2026

ZYGABALIN HARD CAPSULE 150MG
(SIN17442P)

Active Ingredient(s): Pregabalin(150mg)

Application Type: GDA-1

Product Registrant: APEX PHARMA MARKETING PTE. LTD.

Approval Date: 22/01/2026

ZYGABALIN HARD CAPSULE 75MG
(SIN17443P)

Active Ingredient(s): Pregabalin(75mg)

Application Type: GDA-2

Product Registrant: APEX PHARMA MARKETING PTE. LTD.

Approval Date: 22/01/2026

GP-KETOPROFEN PLASTER 30MG/PLASTER
(SIN17441P)

Active Ingredient(s): Ketoprofen(30 mg/plaster)

Application Type: GDA-1

Product Registrant: GOLDPLUS UNIVERSAL PTE LTD

Approval Date: 16/01/2026

EBUNAT SOLUTION FOR INJECTION 0.5MG/ML
(SIN17432P)

Active Ingredient(s): ERIBULIN MESYLATE(0.5 mg/ml)

Application Type: GDA-1

Product Registrant: NATCO PHARMA ASIA PTE. LTD.

Approval Date: 13/01/2026

APIGAT 5 FILM COATED TABLETS 5 MG
(SIN17430P)

Active Ingredient(s): Apixaban(5.00mg)

Application Type: GDA-1

Product Registrant: NATCO PHARMA ASIA PTE. LTD.

Approval Date: 09/01/2026

MICAFUNGIN-AFT POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG/VIAL
(SIN17429P)

Active Ingredient(s): MICAFUNGIN SODIUM EQUIVALENT TO MICAFUNGIN(50MG/vial)

Application Type: GDA-1

Product Registrant: APEX PHARMA MARKETING PTE. LTD.

Approval Date: 09/01/2026

APIGAT 2.5 FILM COATED TABLETS 2.5MG
(SIN17431P)

Active Ingredient(s): Apixaban(2.5mg)

Application Type: GDA-2

Product Registrant: NATCO PHARMA ASIA PTE. LTD.

Approval Date: 09/01/2026

DAPIGA FILM COATED TABLETS 10MG
(SIN17427P)

Active Ingredient(s): Dapagliflozin(10 mg)

Application Type: GDA-1

Product Registrant: SEA PHARMA CONSULTANCY PTE LTD

Approval Date: 06/01/2026

Product Name

Product Information

JAKAVI TABLET 10MG (SIN14927P), JAKAVI TABLET 15MG (SIN14397P), JAKAVI TABLET 20MG (SIN14398P), JAKAVI TABLET 5MG
(SIN14396P)

Active Ingredient(s): Ruxolitinib Phosphate 13.20mg eqv Ruxolinitib(10mg), Ruxolitinib Phosphate 19.80mg eqv Ruxolitinib(15mg), Ruxolitinib Phosphate 26.40mg eqv Ruxolitinib(20mg), Ruxolitinib Phosphate 6.60mg eqv Ruxolitinib(5mg)

Product Registrant: NOVARTIS (SINGAPORE) PTE LTD

Approval Date: 02/04/2026

Indication: Acute Graft-versus-host disease 
Jakavi is indicated for the treatment of patients with acute Graft versus Host Disease (aGvHD) aged 6 years and older who have inadequate response to corticosteroids.
Chronic Graft-versus-host disease
Jakavi is indicated for the treatment of patients with chronic Graft versus Host Disease (cGvHD) aged 6 years and older who have inadequate response to corticosteroids. 

SPRAVATO NASAL SPRAY 28MG/VIAL
(SIN16033P)

Active Ingredient(s): Esketamine HCl 32.2mg eqv. to Esketamine(28mg/vial)

Product Registrant: JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Approval Date: 08/04/2026

Indication: SPRAVATO®, as monotherapy or in combination with an oral antidepressant (SSRI or SNRI), is indicated for treatment-resistant depression (Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat the current depressive episode).

IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML
(SIN15569P)

Active Ingredient(s): Durvalumab(50 mg/ml)

Product Registrant: ASTRAZENECA SINGAPORE PTE LTD

Approval Date: 08/04/2026

Indication: IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by adjuvant IMFINZI monotherapy, is indicated for the treatment of patients with resectable gastric or gastroesophageal junction adenocarcinoma. 

LUTATHERA SOLUTION FOR INFUSION 370 MBQ/ML
(SIN15947P)

Active Ingredient(s): Lutetium (177Lu) oxodotreotide(370 Mbq/ml)

Product Registrant: NOVARTIS (SINGAPORE) PTE LTD

Approval Date: 09/04/2026

Indication: Lutathera® is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in patients aged 12 years and older.

OMNIPAQUE INJECTION 300 MG I/ML (SIN05924P), OMNIPAQUE INJECTION 350 MG I/ML (SIN05923P)

Active Ingredient(s): IOHEXOL 647 mg/ml EQV IODINE(300 mg/ml), IOHEXOL 755 mg/ml EQV IODINE(350 mg/ml)

Product Registrant: GE HEALTHCARE PTE. LTD.

Approval Date: 15/04/2026

Indication:  Contrast enhanced mammography (CEM) in adults to evaluate and detect known or suspected lesions of the breast, as an adjunct to mammography (with or without ultrasound) or as an alternative to magnetic resonance imaging (MRI) when MRI is contraindicated or unavailable.

ADCETRIS® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 50MG/VIAL
(SIN14477P)

Active Ingredient(s): BRENTUXIMAB VEDOTIN(50mg/vial)

Product Registrant: TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Approval Date: 15/04/2026

Indication: Previously untreated Stage IIb with risk factor, Stage III or Stage IV classical Hodgkin Lymphoma (cHL), in combination with chemotherapy.
ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage IIB with risk factors, Stage III or Stage IV cHL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD) (see sections 4.2 and 5.1).

NUBEQA FILM-COATED TABLET 300MG
(SIN16103P)

Active Ingredient(s): Darolutamide milled(300mg)

Product Registrant: BAYER (SOUTH EAST ASIA) PTE LTD

Approval Date: 22/04/2026

Indication: NUBEQA is indicated for the treatment of adult men with - metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1).

LOQTORZI CONCENTRATE FOR SOLUTION FOR INFUSION 240MG/6ML
(SIN17212P)

Active Ingredient(s): Toripalimab(240mg/6mL)

Product Registrant: TA BIOSCIENCES PTE. LTD.

Approval Date: 23/04/2026

Indication: LOQTORZI, in combination with cisplatin and paclitaxel, is indicated for the first-line treatment of adult patients with metastatic or recurrent oesophageal squamous cell carcinoma (OSCC) not amenable to surgery or radiotherapy.

ACAM2000
(SIN13748P)

Active Ingredient(s): LIVE VACCINA VIRUS(1.0 x10⁸ - 5.0 x10⁸ PFU/ml)

Product Registrant: EMERGENT SALES AND MARKETING SINGAPORE PTE. LTD.

Approval Date: 27/04/2026

Indication: ACAM2000 is a vaccine indicated for active immunization for the prevention of mpox disease in adults determined to be at high risk for mpox infection, for use during mpox outbreaks associated with severe or life-threatening disease where alternative vaccines are unavailable or contraindicated.
ACAM2000 should be used in accordance with official recommendations.

LUMAKRAS FILM-COATED TABLET 120MG
(SIN16522P)

Active Ingredient(s): Sotorasib(120mg)

Product Registrant: AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Approval Date: 28/04/2026

Indication: LUMAKRAS, in combination with panitumumab, is indicated for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

KERENDIA FILM-COATED TABLET 10MG, 20MG

Active Ingredient(s): Finerenone(10mg, 20mg)

Product Registrant: BAYER (SOUTH EAST ASIA) PTE LTD 

Approval date: 30/03/2026 

Product Registration Number: SIN16387P, SIN16388P

Indication: Heart Failure (LVEF ≥40%)
Kerendia is indicated for the treatment of symptomatic chronic heart failure and left ventricular ejection fraction (LVEF) ≥40% in adults (See section 5.1.3 Clinical efficacy and safety).

TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 1200 MG/ 20 ML, 840MG/14ML; TECENTRIQ SOLUTION FOR INJECTION 1875MG/15ML

Active Ingredient(s): Atezolizumab(1200 mg, 840mg/14ml, 1875 mg/15ml)

Product Registrant: ROCHE SINGAPORE PTE. LTD.

Approval date: 30/03/2026 

Product Registration Number: SIN15425P, SIN15964P, SIN17033P

Indication: Tecentriq, in combination with lurbinectedin, is indicated for the maintenance treatment of adult patients with ES-SCLC whose disease has not progressed after first-line induction therapy with Tecentriq, carboplatin and etoposide

ZEPZELCA POWDER FOR SOLUTION FOR INFUSION 4MG/VIAL

Active Ingredient(s): Lurbinectedin(4.0 mg/vial)

Product Registrant: SPECIALISED THERAPEUTICS ASIA PTE LTD

Approval date: 30/03/2026 

Product Registration Number: SIN16327P

Indication: ZEPZELCA, in combination with atezolizumab, is indicated for the maintenance treatment of extensive-stage small cell lung cancer (SCLC) in adult patients whose disease has not progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide.

BRAFTOVI HARD CAPSULE 50MG, 75MG

Active Ingredient(s): Encorafenib(50mg)

Product Registrant: PIERRE FABRE SINGAPORE PTE. LTD.

Approval date: 26/03/2026 

Product Registration Number: SIN16825P, SIN16824P

Indication: Non-small cell lung cancer (NSCLC)
Encorafenib, in combination with binimetinib, is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.

MEKTOVI FILM-COATED TABLET 15MG

Active Ingredient(s):Binimetinib(15mg)

Product Registrant:PIERRE FABRE SINGAPORE PTE. LTD.

Approval date:26/03/2026

Product Registration Number:SIN16826P

Indication:Non-small cell lung cancer (NSCLC)
Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600E mutation.

TEVIMBRA CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/10ML

Active Ingredient(s):Tislelizumab(100mg/10mL )

Product Registrant:BEONE MEDICINES SINGAPORE PTE. LTD.

Approval date:19/03/2026

Product Registration Number:SIN17089P

Indication: Tevimbra in combination with platinum-based chemotherapy as neoadjuvant treatment and then continued as Tevimbra monotherapy as adjuvant treatment following surgery is indicated for the treatment of patients with resectable NSCLC at high risk of recurrence and who have no known EGFR mutations or ALK rearrangements.

Tevimbra in combination with etoposide and platinum-containing  chemotherapy is indicated for the first-line treatment of patients with extensive-stage SCLC.

RINVOQ EXTENDED-RELEASE TABLET 15MG, 30MG, 45MG

Active ingredient(s): Upadacitinib Hemihydrate eqv Upadacitinib(15mg, 30mg, 45mg)

Product registrant: ABBVIE PTE. LTD.

Approval date: 18/03/2026

Product Registration Number: SIN15959P, SIN16518P, SIN16687P

Indication: RINVOQ is indicated for the treatment of adults with giant cell arteritis

GENOTROPIN FOR INJECTION 16 IU (5.3 MG) /ML

Active ingredient(s):Somatropin Recombinant(5.3 mg/ml)

Product Registrant:PFIZER PRIVATE LIMITED

Approval date:27/02/2026

Product Registration Number: SIN16968P

Indication: Improvement of growth and body composition in children with Prader Willi syndrome (PWS).

COLUMVI CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML

Active ingredient(s):Glofitamab(1 mg/ml)

Product Registrant:ROCHE SINGAPORE PTE. LTD.

Approval date:24/02/2026

Product Registration Number:SIN16968P

Indication:Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are not candidates for autologous stem cell transplant (ASCT).

DARZALEX SC SOLUTION FOR INJECTION 1800MG/15ML

Active ingredient(s):Daratumumab(1800mg/15mL)

Product Registrant:JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Approval date:20/02/2026

Product Registration Number:SIN16032P

Indication:DARZALEX® SC is indicated for the treatment of patients with multiple myeloma:

- in combination with bortezomib, lenalidomide and dexamethasone in newly diagnosed patients 

MENQUADFI SOLUTION FOR INJECTION

Active ingredient(s): Meningococcal Polysaccharide, Serogroup A (Monovalent Conjugate)(10 mcg/ 0.5 mL),Meningococcal Polysaccharide, Serogroup C (Monovalent Conjugate)(10 mcg/ 0.5 mL),Meningococcal Polysaccharide, Serogroup W-135 (Monovalent Conjugate)(10 mcg / 0.5mL),Meningococcal Polysaccharide, Serogroup Y (Monovalent Conjugate)(10 mcg/ 0.5 mL),Tetanus Toxoid, Filtered Concentrate (Carrier Protein)(55 mcg/ 0.5 mL)

Product Registrant:SANOFI-AVENTIS SINGAPORE PTE. LTD.

Approval date:13/02/2026

Product Registration Number:SIN16454P

Indication:MenQuadfi is indicated for active immunisation of individuals from the age of 6 weeks and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.

The use of this vaccine should be in accordance with available official recommendations.

KISQALI FILM-COATED TABLET 200MG

Active ingredient(s):Ribociclib Succinate 254.4mg eqv Ribociclib(200mg)

Product Registrant:NOVARTIS (SINGAPORE) PTE LTD

Approval date:05/02/2026

Product Registration Number:SIN15407P

Indication:Early breast cancer

Kisqali in combination with an aromatase inhibitor is indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence (see section Clinical studies).

GAMUNEX®-C SOLUTION FOR INFUSION 10%

Active ingredient(s):Human Normal Immunoglobulin(0.1g /mL)

Product Registrant:GRIFOLS ASIA PACIFIC PTE. LTD.

Approval date:29/01/2026

Product Registration Number:SIN14928P

Replacement therapy in adults, children and adolescents (0-18 years) in:
• Primary immunodeficiency syndromes (PID) with impaired antibody production
• Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l
*PSAF = failure to mount at least a 2-fold rise in IgG antibody titer to pneumococcal polysaccharide and polypeptide antigen vaccines

Measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (0-18 years) in whom active immunization is contraindicated or not advised.
Consideration should also be given to official recommendations on intravenous human

Immunomodulation in adults aged ≥18 years in:
• Severe acute exacerbations of myasthenia gravis
Immunomodulation in adults aged ≥18 years in:
• Severe acute exacerbations of myasthenia gravis
immunoglobulin use in measles pre-/post exposure prophylaxis and active immunization.

Immunomodulation in adults, children and adolescents (0-18 years) in:
• Primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count
• Guillain Barré syndrome
• Kawasaki disease (in conjunction with acetylsalicylic acid; see 4.2)
• Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
• Multifocal motor neuropathy (MMN)

ZAVICEFTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2G/0.5G

Active ingredient(s):Avibactam sodium 543.5 mg eqv. to Avibactam(500mg),Ceftazidime pentahydrate 2329.7 mg eqv. to Ceftazidime(2g)

Product Registrant:PFIZER PRIVATE LIMITED

Approval date:15/01/2026

Product Registration Number:SIN15870P

Indication:Zavicefta is indicated in adults and paediatric patients from birth for the treatment of the
following infections (see sections 4.4 and 5.1):
- Complicated Intra-Abdominal Infection (cIAI)
- Complicated Urinary Tract Infection (cUTI), including pyelonephritis
- Hospital-acquired Pneumonia (HAP), including ventilator associated pneumonia (VAP)