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HSA Approval

PEMAZYRE TABLETS 13.5 MG

Approval Number

SIN17044P

Drug Name

PEMAZYRE TABLETS 13.5 MG

Product Name

PEMAZYRE TABLETS 13.5 MG

Approval Date

July 9, 2024

Registrant

SPECIALISED THERAPEUTICS ASIA PTE LTD

Regulatory Information

Registrant

SPECIALISED THERAPEUTICS ASIA PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

TABLET

Route of Administration

ORAL

Medical Information

ATC Code

L01EN02

Manufacturer Information

Pharmaceutical Manufacturer

SPECIALISED THERAPEUTICS ASIA PTE. LTD.

Manufacturers

Lonza Tampa LLC

Active Ingredients

Ingredient Name

Pemigatinib

Strength

13.50 mg

Drug MonographPemigatinib

Documents

Package Inserts

Pemazyre Tablet PI.pdf

Approved: July 9, 2024

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