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HSA Approval

Besremi Solution for Injection in Prefilled Syringe 500 micrograms/mL

Approval Number

SIN17014P

Drug Name

Besremi Solution for Injection in Prefilled Syringe 500 micrograms/mL

Product Name

Besremi Solution for Injection in Prefilled Syringe 500 micrograms/mL

Approval Date

May 29, 2024

Registrant

PHARMAESSENTIA SINGAPORE PTE. LTD

Regulatory Information

Registrant

PHARMAESSENTIA SINGAPORE PTE. LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, SOLUTION

Route of Administration

SUBCUTANEOUS

Medical Information

ATC Code

L03AB15

Manufacturer Information

Pharmaceutical Manufacturer

PHARMAESSENTIA SINGAPORE PTE. LTD.

Manufacturers

PharmaEssentia Corporation, Taichung Plant

Active Ingredients

Ingredient Name

Ropeginterferon alfa-2b

Strength

500 µg/mL

Drug MonographRopeginterferon alfa-2b

Documents

Package Inserts

BESREMi PI.pdf

Approved: May 29, 2024

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