| 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). | |
HSA: Health Sciences Authority
Link to the HSA announcement: https://www.hsa.gov.sg/announcements/new-drug-indication-approvals/new-drug-indication-approval—june-2024
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