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Health Sciences Authority
New Drug Indication Approvals

New drug indication approval - June 2024

Audiences

Healthcare professional

Industry member

Product type

Therapeutic Products

6 August 2024

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

For the most updated information related to registered therapeutic products, please refer to the Register of Therapeutic Products.

Table caption

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.

Table caption

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).

*Evaluated as part of Project Orbis.

Table caption

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).

*Evaluated as part of Project Orbis.


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