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HSA Approval

Besremi Solution for Injection in Prefilled Syringe 500 micrograms/mL

SIN17014P

Besremi Solution for Injection in Prefilled Syringe 500 micrograms/mL

Besremi Solution for Injection in Prefilled Syringe 500 micrograms/mL

May 29, 2024

PHARMAESSENTIA SINGAPORE PTE. LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantPHARMAESSENTIA SINGAPORE PTE. LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, SOLUTION

SUBCUTANEOUS

Medical Information

L03AB15

Manufacturer Information

PHARMAESSENTIA SINGAPORE PTE. LTD.

PharmaEssentia Corporation, Taichung Plant

Active Ingredients

Ropeginterferon alfa-2b

500 µg/mL

Documents

Package Inserts

BESREMi PI.pdf

Approved: May 29, 2024

Download

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Besremi Solution for Injection in Prefilled Syringe 500 micrograms/mL - HSA Approval | MedPath