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HSA Approval

WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 60MG

SIN17092P

WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 60MG

WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 60MG

September 20, 2024

MSD PHARMA (SINGAPORE) PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantMSD PHARMA (SINGAPORE) PTE. LTD.

Product Classification

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

Formulation Information

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

SUBCUTANEOUS

Medical Information

C02KX06

Manufacturer Information

MSD PHARMA (SINGAPORE) PTE. LTD.

Patheon Italia S.p.A

Vetter Pharma-Fertigung GmbH & Co. KG

Active Ingredients

(Powder vial) sotatercept

60mg

Sotatercept

Documents

Package Inserts

Winrevair Injection Kit IFU 2S.pdf

Approved: September 20, 2024

Download

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WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 60MG - HSA Approval | MedPath