New drug indication approval - January 2025
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| Product Name | BALVERSA FILM-COATED TABLETS 3MG,
BALVERSA FILM-COATED TABLETS 4MG,
BALVERSA FILM-COATED TABLETS 5MG |
|---|
| Active Ingredient (Strength) | Erdafitinib(3.00 mg),
Erdafitinib(4.00 mg),
Erdafitinib(5.00 mg) |
| Product Registrant | JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD |
| Date of Approval | 03/01/2025 |
Indications:
BALVERSA™ is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor (FGFR) 3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy (see Pharmacodynamic Effects - Clinical studies).
Select patients for therapy based on a companion diagnostic for Balversa™.
Limitations of Use
BALVERSA™ is not recommended for the treatment of patients who are eligible for and have not received prior programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy. |
| Product Name | PERTAGEN® SUSPENSION FOR INJECTION 0.5 ML/DOSE |
|---|
| Active Ingredient (Strength) | Filamentous Haemagglutinin (FHA)(5 ug/0.5 ml),Recombinant Pertussis Toxin (rPT)(5 ug/0.5 ml) |
| Product Registrant | NOVEM HEALTHCARE PTE LTD |
| Date of Approval | 16/01/2025 |
Indications:
Pertagen® is indicated for active booster immunization against pertussis in individuals from the age of 3 years onwards.
Pertagen® is indicated for maternal immunization in pregnant women for the prevention of pertussis in infants too young to be vaccinated.
Pertagen® should be used in accordance with official recommendations for booster vaccination and maternal immunization against pertussis only. |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals