Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantBIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
INJECTION
INTRAMUSCULAR
Medical Information
J07BX03
Manufacturer Information
BIONTECH PHARMACEUTICALS ASIA PACIFIC PTE. LTD.
Pfizer Manufacturing Belgium NV
Active Ingredients
Bretovameran
30 μg/dose
bretovameran
Documents
Package Inserts
Comirnaty Dispersion for Injection in Prefilled Syringe 30mcg PI.pdf
Approved: May 13, 2025
Patient Information Leaflets
Comirnaty Dispersion for Injection in Prefilled Syringe 30mcg PIL.pdf
Approved: May 13, 2025