Listing of approvals 

View the lists of therapeutic products approvals and new indications approved for registered therapeutic products. 

For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

New Drug Applications (NDA)

  • Please click here for a list of summary reports of benefit-risk assessments.
  • Please click here for description of application types.


 

Approval Date

Product Name

Active Ingredient(s)

Application Type

Product Registrant

Licence Number

24/03/2026

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

Flurbiprofen(8.748mg/dose)

NDA-2

RECKITT BENCKISER (SINGAPORE) PTE LTD

SIN17495P

23/03/2026

DIFFLAM PLUS ANAESTHETIC SORE THROAT SPRAY

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

NDA-2

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

SIN17493P

19/03/2026

TANSTRIVE TABLETS 40MG

Selpercatinib(40mg)

NDA-2

DKSH SINGAPORE PTE. LTD.

SIN17487P

19/03/2026

TANSTRIVE TABLETS 80MG

Selpercatinib(80mg)

NDA-3

DKSH SINGAPORE PTE. LTD.

SIN17488P

16/03/2026

EVRYSDI FILM-COATED TABLET 5MG

Risdiplam(5.000 mg)

NDA-2

ROCHE SINGAPORE PTE. LTD.

SIN17484P

16/03/2026

TIBSOVO FILM-COATED TABLET 250MG

Ivosidenib(250.0mg)

NDA-1

SERVIER (S) PTE LTD

SIN17485P

06/03/2026

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

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

NDA-1

MODERNA BIOTECH SINGAPORE PTE. LTD.

SIN17482P

20/02/2026

CAPVAXIVE SOLUTION FOR INJECTION

(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)

NDA-1

MSD PHARMA (SINGAPORE) PTE. LTD.

SIN17471P

13/02/2026

FLUARIX SUSPENSION FOR INJECTION

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)

NDA-2

GLAXOSMITHKLINE PTE LTD

SIN17468P

12/02/2026

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

* Evaluated via Access

Clesrovimab(105mg/0.7mL)

NDA-1

MSD PHARMA (SINGAPORE) PTE. LTD.

SIN17467P

09/02/2026

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

(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)

NDA-2

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SIN17460P

15/01/2026

EMBLAVEO POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 1.5G/0.5G

* Evaluated via ASEAN Joint review

Avibactam Sodium eqv Avibactam(0.5 g/vial ),Aztreonam(1.5 g/vial)

NDA-2

PFIZER PRIVATE LIMITED

SIN17438P

15/01/2026

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

Denosumab(60 mg/ml)

NDA-2: Biosimilar

SANDOZ SINGAPORE PTE. LTD.

SIN17439P

15/01/2026

WYOST SOLUTION FOR INJECTION 120MG/1.7ML

Denosumab(120 mg/1.7ml)

NDA-2: Biosimilar

SANDOZ SINGAPORE PTE. LTD.

SIN17440P

14/01/2026

VALTOCO NASAL SPRAY 10MG/SPRAY

Diazepam(10mg/spray)

NDA-2

RXILIENT MEDICAL PTE LTD

SIN17435P

14/01/2026

VALTOCO NASAL SPRAY 5MG/SPRAY

Diazepam(5.00mg/spray)

NDA-3

RXILIENT MEDICAL PTE LTD

SIN17437P

14/01/2026

VALTOCO NASAL SPRAY 7.5MG/SPRAY

Diazepam(7.5mg/ spray)

NDA-3

RXILIENT MEDICAL PTE LTD

SIN17436P

13/01/2026

FRAGMIN SOLUTION FOR INJECTION PREFILLED SYRINGE 2500 IU/0.2 ML

Dalteparin Sodium(2500 IU/0.2ml)

NDA-2

PFIZER PRIVATE LIMITED

SIN17433P

13/01/2026

FRAGMIN SOLUTION FOR INJECTION PREFILLED SYRINGE 5000 IU/0.2 ML

Dalteparin Sodium(5000 IU/0.2ml)

NDA-3

PFIZER PRIVATE LIMITED

SIN17434P

07/01/2026

PAXLOVID (NIRMATRELVIR AND RITONAVIR) FILM-COATED TABLETS

Nirmatrelvir(150 mg),Ritonavir(100 mg)

NDA-2

PFIZER PRIVATE LIMITED

SIN17428P

Click here to view older listings of new drug approvals

Generic Drug Applications (GDA)

 

Approval Date

Product Name

Active Ingredient(s)

Application Type

Product Registrant

Licence Number

30/03/2026

ANICURA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG

Anidulafungin(100 mg)

GDA-1

INTEGA PTE LTD

SIN17508P

27/03/2026

XABAREM FILM-COATED TABLETS 20 MG

Rivaroxaban(20 mg)

GDA-1

GOLDPLUS UNIVERSAL PTE LTD

SIN17504P

27/03/2026

XABAREM FILM-COATED TABLETS 15 MG

Rivaroxaban(15 mg)

GDA-2

GOLDPLUS UNIVERSAL PTE LTD

SIN17505P

27/03/2026

XABAREM FILM-COATED TABLETS 10 MG

Rivaroxaban(10 mg)

GDA-2

GOLDPLUS UNIVERSAL PTE LTD

SIN17506P

27/03/2026

XABAREM FILM-COATED TABLETS 2.5 MG

Rivaroxaban(2.5 mg )

GDA-2

GOLDPLUS UNIVERSAL PTE LTD

SIN17507P

26/03/2026

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

Bendamustine Hydrochloride Monohydrate equivalent to Bendamustine Hydrochloride(25 mg/vial)

GDA-1

ADVAGEN PTE. LTD.

SIN17502P

26/03/2026

XYLOCREAM 5% W/W

Lidocaine(2.5 % w/w),Prilocaine(2.5 % w/w)

GDA-1

GOLDPLUS UNIVERSAL PTE LTD

SIN17501P

26/03/2026

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

Bendamustine Hydrochloride Monohydrate equivalent to Bendamustine Hydrochloride(100 mg/vial)

GDA-2

ADVAGEN PTE. LTD.

SIN17503P

25/03/2026

ATSWIFT-EZ FILM COATED TABLETS 80MG/10MG

Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(80 mg ),Ezetimibe(10 mg )

GDA-1

GOLDPLUS UNIVERSAL PTE LTD

SIN17496P

25/03/2026

DYDROGESTERONE INTEGA FILM COATED TABLET 10MG

Dydrogesterone(10.00 mg)

GDA-1

INTEGA PTE LTD

SIN17500P

25/03/2026

ATSWIFT-EZ FILM COATED TABLETS 40MG/10MG

Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(40 mg ),Ezetimibe(10 mg )

GDA-2

GOLDPLUS UNIVERSAL PTE LTD

SIN17497P

25/03/2026

ATSWIFT-EZ FILM COATED TABLETS 20MG/10MG

Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(20 mg ),Ezetimibe(10 mg )

GDA-2

GOLDPLUS UNIVERSAL PTE LTD

SIN17498P

25/03/2026

ATSWIFT-EZ FILM COATED TABLETS 10MG/10MG

Atorvastatin Calcium Trihydrate equivalent to Atorvastatin(10 mg ),Ezetimibe(10 mg )

GDA-2

GOLDPLUS UNIVERSAL PTE LTD

SIN17499P

24/03/2026

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

Dextromethorphan hydrobromide eqv. Dextromethorphan(15mg/5mL)

GDA-1

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

SIN17494P

23/03/2026

MELIFORT EXTENDED RELEASE TABLET 500MG

Metformin Hydrochloride(500mg)

GDA-2

APEX PHARMA MARKETING PTE. LTD.

SIN17492P

23/03/2026

MELIFORT EXTENDED RELEASE TABLET 750MG

Metformin Hydrochloride(750mg)

GDA-2

APEX PHARMA MARKETING PTE. LTD.

SIN17491P

23/03/2026

MELIFORT EXTENDED RELEASE TABLET 1000MG

Metformin Hydrochloride(1000mg)

GDA-1

APEX PHARMA MARKETING PTE. LTD.

SIN17490P

20/03/2026

AMOKLAVIN-BID FILM COATED TABLETS 1000 MG

Amoxicillin Trihydrate eqv Amoxicillin(875 mg ),Potassium Clavulanate eqv Clavulanic Acid(125 mg)

GDA-1

GOLDPLUS UNIVERSAL PTE LTD

SIN17489P

19/03/2026

AIRKEFAY FILM-COATED TABLETS 200MG

Sorafenib Tosylate eqv Sorafenib(200mg)

GDA-1

KEXING BIOPHARMA SINGAPORE PTE. LTD.

SIN17486P

10/03/2026

MEGVAL™ POWDER FOR SOLUTION FOR INJECTION 50MG/VIAL

Melphalan Hydrochloride eqv Melphalan(50 mg/vial)

GDA-1

ADVAGEN PTE. LTD.

SIN17483P

04/03/2026

RESPIRO AEROSOL INHALER 25MCG/250MCG PER DOSE

Fluticasone propionate(250 mcg/dose),Salmeterol xinafoate equivalent to salmeterol(25 mcg/dose)

GDA-1

GOLDPLUS UNIVERSAL PTE LTD

SIN17479P

04/03/2026

RHINOLONE NASAL SPRAY 55 MICROGRAMS/DOSE

Triamcinolone acetonide(55 mcg/dose)

GDA-1

NOVEM HEALTHCARE PTE LTD

SIN17481P

04/03/2026

RESPIRO AEROSOL INHALER 25 MCG/125 MCG PER DOSE

Fluticasone propionate(125 mcg/dose),Salmeterol xinafoate equivalent to salmeterol(25 mcg/dose)

GDA-2

GOLDPLUS UNIVERSAL PTE LTD

SIN17480P

03/03/2026

INSTADIP 100 FILM COATED TABLET USP 100 MG

Sitagliptin Phosphate eq to Sitagliptin(100 mg)

GDA-1

RANBAXY (MALAYSIA) SDN. BHD.

SIN17478P

03/03/2026

INSTADIP 25 FILM COATED TABLET USP 25MG

Sitagliptin Phosphate eq to Sitagliptin(25 mg)

GDA-2

RANBAXY (MALAYSIA) SDN. BHD.

SIN17477P

03/03/2026

INSTADIP 50 FILM COATED TABLET USP 50MG

Sitagliptin Phosphate eq to Sitagliptin(50 mg)

GDA-2

RANBAXY (MALAYSIA) SDN. BHD.

SIN17476P

27/02/2026

DREXRED 500 LEVETIRACETAM FILM-COATED TABLETS 500 MG

LEVETIRACETAM(500.00 MG)

GDA-1

ZYFAS PHARMA PTE LTD

SIN17475P

27/02/2026

OLANZAPINE-TEVA FC TABLET 5MG

Olanzapine(5 mg)

GDA-2

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

SIN17473P

27/02/2026

OLANZAPINE-TEVA FC TABLET 10MG

Olanzapine(10 mg)

GDA-1

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

SIN17474P

24/02/2026

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

Atorvastatin Calcium Trihydrate (Form 1) equivalent to atorvastatin(40mg)

GDA-2

ZYFAS PHARMA PTE LTD

SIN17472P

16/02/2026

TACHYBAN (ADENOSINE INJECTION USP) 3MG/ML

Adenosine(3mg/ml)

GDA-1

SIXMURS SINGAPORE PTE. LTD.

SIN17470P

14/02/2026

DAFASGLIT 10 FILM-COATED TABLETS 10MG

Dapagliflozin(10.000 mg)

GDA-1

APOTHECA MARKETING PTE LTD

SIN17469P

11/02/2026

ROST 20 ROSUVASTATIN TABLETS 20 MG

Rosuvastatin Calcium equivalent to Rosuvastatin(20.000 mg)

GDA-1

HETERO SINGAPORE PTE. LTD.

SIN17466P

11/02/2026

ROST 10 ROSUVASTATIN TABLETS 10 MG

Rosuvastatin Calcium equivalent to Rosuvastatin(10.000 mg)

GDA-2

HETERO SINGAPORE PTE. LTD.

SIN17465P

10/02/2026

ZYROXABAN FILM COATED TABLET 15MG

Rivaroxaban (micronised)(15mg)

GDA-2

APEX PHARMA MARKETING PTE. LTD.

SIN17462P

10/02/2026

ZYROXABAN FILM COATED TABLET 10MG

RIVAROXABAN (MICRONISED)(10MG)

GDA-2

APEX PHARMA MARKETING PTE. LTD.

SIN17463P

10/02/2026

ZYROXABAN FILM COATED TABLET 20MG

Rivaroxaban (micronised)(20mg)

GDA-1

APEX PHARMA MARKETING PTE. LTD.

SIN17461P

10/02/2026

OBITOCIN SOLUTION FOR INJECTION IN PREFILLED SYRINGE 100MCG/ML

Carbetocin(100 mcg/ml)

GDA-1

UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED

SIN17464P

09/02/2026

ESOMEPRAZOLE AUXILTO GASTRO-RESISTANT TABLETS 40MG

Esomeprazole Magnesium Trihydrate eqv. Esomeprazole(40mg)

GDA-1

AUXILTO IMPEX PTE. LTD.

SIN17454P

09/02/2026

TORVASTATIN FC TABLET 80MG

Atorvastatin Calcium eqv to Atorvastatin(80mg)

GDA-1

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

SIN17456P

09/02/2026

ESOMEPRAZOLE AUXILTO GASTRO-RESISTANT TABLETS 20MG

Esomeprazole Magnesium Trihydrate eqv. Esomeprazole(20mg)

GDA-2

AUXILTO IMPEX PTE. LTD.

SIN17455P

09/02/2026

TORVASTATIN FC TABLET 40MG

Atorvastatin Calcium eqv to Atorvastatin(40mg)

GDA-2

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

SIN17457P

09/02/2026

TORVASTATIN FC TABLET 20MG

Atorvastatin Calcium eqv to Atorvastatin(20mg)

GDA-2

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

SIN17458P

09/02/2026

TORVASTATIN FC TABLET 10MG

Atorvastatin Calcium eqv to Atorvastatin(10mg)

GDA-2

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

SIN17459P

04/02/2026

NOREPINEPHRINE SCIGEN CONCENTRATE FOR SOLUTION FOR INFUSION 4 MG/4ML

Norepinephrine Bitartrate eqv. Norephinephrine(4mg/4ml)

GDA-1

SCIGEN PTE. LTD.

SIN17453P

03/02/2026

TRANEXAMIC ACID MEVON FILM-COATED TABLETS 500 MG

Tranexamic acid(500.00 mg)

GDA-1

NOVEM HEALTHCARE PTE LTD

SIN17452P

02/02/2026

RIVAROXABAN-TEVA FC TABLET 2.5MG

Rivaroxaban(2.5 mg)

GDA-2

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

SIN17451P

02/02/2026

RIVAROXABAN-TEVA FC TABLET 20MG

Rivaroxaban(20 mg)

GDA-1

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

SIN17448P

02/02/2026

RIVAROXABAN-TEVA FC TABLET 10MG

Rivaroxaban(10 mg)

GDA-2

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

SIN17450P

02/02/2026

RIVAROXABAN-TEVA FC TABLET 15MG

Rivaroxaban(15 mg)

GDA-2

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

SIN17449P

29/01/2026

PHENASEN CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/10ML

Arsenic Trioxide(10mg/10ml)

GDA-1

PHEBRA (SE ASIA) PTE. LTD.

SIN17447P

27/01/2026

MOXICLAV POWDER FOR SOLUTION FOR INJECTION/ INFUSION 1.2G/VIAL

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

GDA-1

MEDOCHEMIE SINGAPORE PTE. LTD.

SIN17446P

23/01/2026

JAMP-CHOLESTYRAMINE POWDER FOR ORAL SUSPENSION 4G

Cholestyramine resin(4000mg)

GDA-1

GOLDPLUS UNIVERSAL PTE LTD

SIN17445P

22/01/2026

ZYGABALIN HARD CAPSULE 50MG

Pregabalin(50mg)

GDA-2

APEX PHARMA MARKETING PTE. LTD.

SIN17444P

22/01/2026

ZYGABALIN HARD CAPSULE 150MG

Pregabalin(150mg)

GDA-1

APEX PHARMA MARKETING PTE. LTD.

SIN17442P

22/01/2026

ZYGABALIN HARD CAPSULE 75MG

Pregabalin(75mg)

GDA-2

APEX PHARMA MARKETING PTE. LTD.

SIN17443P

16/01/2026

GP-KETOPROFEN PLASTER 30MG/PLASTER

Ketoprofen(30 mg/plaster)

GDA-1

GOLDPLUS UNIVERSAL PTE LTD

SIN17441P

13/01/2026

EBUNAT SOLUTION FOR INJECTION 0.5MG/ML

ERIBULIN MESYLATE(0.5 mg/ml)

GDA-1

NATCO PHARMA ASIA PTE. LTD.

SIN17432P

09/01/2026

APIGAT 5 FILM COATED TABLETS 5 MG

Apixaban(5.00mg)

GDA-1

NATCO PHARMA ASIA PTE. LTD.

SIN17430P

09/01/2026

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

MICAFUNGIN SODIUM EQUIVALENT TO MICAFUNGIN(50MG/vial)

GDA-1

APEX PHARMA MARKETING PTE. LTD.

SIN17429P

09/01/2026

APIGAT 2.5 FILM COATED TABLETS 2.5MG

Apixaban(2.5mg)

GDA-2

NATCO PHARMA ASIA PTE. LTD.

SIN17431P

06/01/2026

DAPIGA FILM COATED TABLETS 10MG

Dapagliflozin(10 mg)

GDA-1

SEA PHARMA CONSULTANCY PTE LTD

SIN17427P


Major Variation Applications (MAV)


Approval DateProduct NameActive Ingredient(s)Product RegistrantLicence NumberIndication
27/02/2026

GENOTROPIN FOR INJECTION 16 IU (5.3 MG) /ML

Somatropin Recombinant(5.3 mg/ml)

PFIZER PRIVATE LIMITED

SIN05273P

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

24/02/2026

COLUMVI CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML

Glofitamab(1 mg/ml)

ROCHE SINGAPORE PTE. LTD.

SIN16968P

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).

20/02/2026

DARZALEX SC SOLUTION FOR INJECTION 1800MG/15ML

Daratumumab(1800mg/15mL)

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

SIN16032P

DARZALEX® SC is indicated for the treatment of patients with multiple myeloma:
- in combination with bortezomib, lenalidomide and dexamethasone in newly diagnosed patients 
13/02/2026

MENQUADFI SOLUTION FOR INJECTION

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)

SANOFI-AVENTIS SINGAPORE PTE. LTD.

SIN16454P

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.

05/02/2026

KISQALI FILM-COATED TABLET 200MG

Ribociclib Succinate 254.4mg eqv Ribociclib(200mg)

NOVARTIS (SINGAPORE) PTE LTD

SIN15407P

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).

29-01-2026GAMUNEX®-C SOLUTION FOR INFUSION 10%Human Normal Immunoglobulin(0.1g /mL)GRIFOLS ASIA PACIFIC PTE. LTD.SIN14928PReplacement 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)
15-01-2026ZAVICEFTA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 2G/0.5GAvibactam sodium 543.5 mg eqv. to Avibactam(500mg),Ceftazidime pentahydrate 2329.7 mg eqv. to Ceftazidime(2g)PFIZER PRIVATE LIMITEDSIN15870PZavicefta 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)

Click here to view older listings of drug indication approvals.

Reclassifications

View the list of reclassified therapeutic products (MAV-2).