Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantPHARMENG TECHNOLOGY PTE. LTD.
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
INJECTION, SUSPENSION
INTRAMUSCULAR
Medical Information
J07BB01
influenza, inactivated, whole virus
Manufacturer Information
PHARMENG TECHNOLOGY PTE. LTD.
Baxter AG
Active Ingredients
A/Vietnam/1203/2004 (H5N1)
7.5µg haemagglutinin per 0.5ml
Documents
Package Inserts
Baxter H5N1 vaccine PI.pdf
Approved: December 19, 2012