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HSA Approval

WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG (VIAL ONLY)

SIN17093P

WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG (VIAL ONLY)

WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG (VIAL ONLY)

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

Active Ingredients

sotatercept

45mg

Sotatercept

Documents

Package Inserts

Winrevair Injection vial PI.pdf

Approved: September 20, 2024

Download

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WINREVAIR® POWDER FOR SOLUTION FOR INJECTION 45MG (VIAL ONLY) - HSA Approval | MedPath