Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantPFIZER PRIVATE LIMITED
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
INTRAMUSCULAR
Medical Information
J07BX05
Manufacturer Information
PFIZER PRIVATE LIMITED
Pfizer Manufacturing Belgium NV
Pfizer Manufacturing Belgium NV (Diluent)
Active Ingredients
(Powder) RSV subgroup A stabilized prefusion F protein
0.06 mg/vial
(powder) rsv subgroup a stabilized prefusion f protein
(Powder) RSV subgroup B stabilized prefusion F protein
0.06 mg/vial
(powder) rsv subgroup b stabilized prefusion f protein
Documents
Package Inserts
Abrysvo PI.pdf
Approved: July 23, 2024