| Product Name | AUDENZ® PANDEMIC INFLUENZA VACCINE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE | | Active Ingredient (Strength) | Influenza virus surface antigens (haemagglutinin and neuraminidase)(7.5 micrograms HA per 0.5 mL dose) | | Application type | NDA-2 | | Product Registrant | SEQIRUS PTE. LTD. | | Date of Approval | 29/10/2025 | | Registration No. | SIN17377P | Indications:
AUDENZ® is indicated for active immunisation against influenza A in persons from 6
months of age and older in an officially declared pandemic.
AUDENZ® should be used in accordance with official recommendations.
The available evidence was based on immunogenicity studies conducted in healthy subjects following administration of two doses of monovalent vaccine of different influenza subtypes. See also Section 5.1 Pharmacodynamic properties - Clinical trials |
| Product Name | CELLDEMIC® PRE-PANDEMIC INFLUENZA VACCINE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE | | Active Ingredient (Strength) | Influenza virus surface antigens (haemagglutinin and neuraminidase) A/turkey/Turkey/1/2005(H5N1)-like strain used (NIBRG-23)(7.5 micrograms HA per 0.5 mL dose) | | Application type | NDA-2 | | Product Registrant | SEQIRUS PTE. LTD. | | Date of Approval | 16/10/2025 | | Registration No. | SIN17363P | Indications:
CELLDEMIC® is indicated for active immunisation against the H5 subtype of Influenza A virus in persons from 6 months of age and older. CELLDEMIC® should be used in accordance with official recommendations. |
| Product Name | LAZCLUZE FILM-COATED TABLETS 80MG,
LAZCLUZE FILM-COATED TABLETS 240MG | | Active Ingredient (Strength) | Lazertinib Mesylate Monohydrate eqv Lazertinib(80 mg),
Lazertinib Mesylate Monohydrate eqv Lazertinib(240 mg) | | Application type | NDA-1,
NDA-3 | | Product Registrant | JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD | | Date of Approval | 02/10/2025 | | Registration No. | SIN17349P,
SIN17348P | Indications:
LAZCLUZE® in combination with amivantamab is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
* Evaluated via Project ORBIS |
| Product Name | MOUNJARO SOLUTION FOR INJECTION IN VIAL 2.5MG / 0.5ML,
MOUNJARO SOLUTION FOR INJECTION IN VIAL 5MG / 0.5ML,
MOUNJARO SOLUTION FOR INJECTION IN VIAL 7.5MG / 0.5ML,
MOUNJARO SOLUTION FOR INJECTION IN VIAL 10MG / 0.5ML,
MOUNJARO SOLUTION FOR INJECTION IN VIAL 12.5MG / 0.5ML,
MOUNJARO SOLUTION FOR INJECTION IN VIAL 15MG / 0.5ML | | Active Ingredient (Strength) | Tirzepatide(2.5mg/0.5mL),
Tirzepatide(5mg/0.5mL),
Tirzepatide(7.5mg/0.5mL),
Tirzepatide(10mg/0.5mL),
Tirzepatide(12.5mg/0.5mL),
Tirzepatide(15mg/0.5mL) | | Application type | NDA-2, NDA-3
| | Product Registrant | DKSH SINGAPORE PTE. LTD. | | Date of Approval | 10/10/2025 | | Registration No. | SIN17351P,
SIN17352P,
SIN17353P,
SIN17354P,
SIN17355P,
SIN17356P | Indications:
Type 2 diabetes mellitus
Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
• in addition to other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1.
Weight management
Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of
• ≥ 30 kg/m2 (obesity) or
• ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus |
| Product Name | SCEMBLIX FILM-COATED TABLET 100 MG | | Active Ingredient (Strength) | Asciminib hydrochloride eqv asciminib(100 mg) | | Application type | NDA-3 | | Product Registrant | NOVARTIS (SINGAPORE) PTE LTD | | Date of Approval | 06/10/2025 | | Registration No. | SIN17350P | Indications:
Scemblix® is indicated for the treatment of adult patients with:
•Newly diagnosed or previously treated Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
•Ph+ CML in CP harboring the T315I mutation. |
| Product Name | XGEVA SOLUTION FOR INJECTION IN PRE‐FILLED SYRINGE 120 MG/ML | | Active Ingredient (Strength) | Denosumab(120mg/mL) | | Application type | NDA-2 | | Product Registrant | AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD | | Date of Approval | 17/10/2025 | | Registration No. | SIN17364P | Indications:
Prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in patients with multiple myeloma and in patients with bone metastases from solid tumours.
Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity. |
| Product Name | XTANDI™ FILM-COATED TABLETS 80MG,
XTANDI™ FILM-COATED TABLETS 40MG | | Active Ingredient (Strength) | Enzalutamide(80mg),
Enzalutamide(40mg) | | Application type | NDA-2,
NDA-3 | | Product Registrant | ASTELLAS PHARMA SINGAPORE PTE. LTD. | | Date of Approval | 21/10/2025 | | Registration No. | SIN17369P,
SIN17368P | Indications:
Xtandi is indicated:
• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 4.4, 4.8 and 5.1).
• for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1).
• for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).
• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1).
• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. | |