New drug indication approval - April 2024
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| Product Name | ATGAM INJECTION 50 MG/ML |
| Active Ingredient (Strength) | HORSE GAMMA GLOBULIN(50 mg/ml) |
| Product Registrant | PFIZER PRIVATE LIMITED |
| Date of Approval | 18/04/2024 |
Indications:
ATGAM is indicated for use in adults and in children aged 2 years and older for the treatment of moderate to severe aplastic anemia in patients who are unsuitable for bone marrow transplantation. |
| Product Name | KEYTRUDA SOLUTION FOR INFUSION 25MG/ML |
| Active Ingredient (Strength) | PEMBROLIZUMAB(25MG/ML) |
| Product Registrant | MSD PHARMA (SINGAPORE) PTE LTD |
| Date of Approval | 29/04/2024 |
Indications:
Keytruda, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test. |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals