New drug indication approval - June 2024
For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.
| Product Name | XEOMIN® POWDER FOR SOLUTION FOR INJECTION 100 UNITS/VIAL,
XEOMIN® POWDER FOR SOLUTION FOR INJECTION 50 UNITS/VIAL |
| Active Ingredient (Strength) | Clostridium Botulinum neurotoxin type A (150 kDa), free from complexing proteins(100 LD50 units),
Clostridium Botulinum neurotoxin type A (150 kDa), free from complexing proteins(50 LD50 units) |
| Product Registrant | MERZ ASIA PACIFIC PTE. LTD. |
| Date of Approval | 20/06/2024 |
Indications:
Chronic sialorrhea in patients 2 years of age and older due to neurological disorders. |
| Product Name | TAFINLAR HARD CAPSULE 50MG,
TAFINLAR HARD CAPSULE 75MG |
| Active Ingredient (Strength) | Dabrafenib Mesylate 59.25mg equivalent to dabrafenib(50mg),
Dabrafenib Mesylate 88.88mg equivalent to dabrafenib(75mg) |
| Product Registrant | NOVARTIS (SINGAPORE) PTE LTD |
| Date of Approval | 03/06/2024 |
Indications:
Dabrafenib in combination with trametinib is indicated for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy (see section 12 Clinical studies). |
| Product Name | MEKINIST FILM-COATED TABLETS 0.5MG,
MEKINIST FILM-COATED TABLETS 2MG |
| Active Ingredient (Strength) | Trametinib Dimethyl Sulfoxide 0.5635mg eqv trametinib(0.5mg),
Trametinib Dimethyl Sulfoxide 2.254mg eqv trametinib(2mg) |
| Product Registrant | NOVARTIS (SINGAPORE) PTE LTD |
| Date of Approval | 03/06/2024 |
Indications:
Trametinib in combination with dabrafenib is indicated for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy (see section 12 Clinical studies). |
Healthcare professional, Industry member, Therapeutic Products
Published:
New Drug Indication Approvals