| Product Information |
|
| Registration Number |
BR-513
|
| Generic Name |
Hepatitis A Vaccine (Inactivated, Adsorbed)
|
| Brand Name |
Avaxim 80
|
| Dosage Strength |
Formulation:
Each dose (0.5 mL) contains:
Hepatitis A virus, GBM Strain* (inactivated)** 80 ELISA units***
*Cultured on MRC-5 human diploid cells
** Adsorbed on hydrated aluminum hydroxide (0.15 mg of Al3)
*** In the absence of an international standardised reference, the antigen content is expressed using an in-house reference
|
| Dosage Form |
Suspension for Injection (IM)
|
| Classification |
Prescription Drug (RX)
|
| Packaging |
Type I pre-filled glass syringe with heat marker
x 0.5 mL (Box of 1's); Type I pre-filled glass syringe x 0.5 mL (Box of 1's)
|
| Pharmacologic Category |
-
|
| Manufacturer |
Sanofi Pasteur
|
| Country of Origin |
France
|
| Trader |
N/A
|
| Importer |
Sanofi Pasteur, Inc.
|
| Distributor |
Zuellig Pharma Corporation
|
| Application Type |
Renewal
|
| Issuance Date |
30 January 2023
|
| Expiry Date |
05 December 2027
|