Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: MSD VACCINS, 162 avenue Jean Jaurès, 69007, Lyon, France
HBVAXPRO 5 micrograms, suspension for injection.
Hepatitis B vaccine (recombinant DNA).
| Pharmaceutical Form |
|---|
|
Suspension for injection. Slightly opaque white suspension. |
One dose (0.5 ml) contains: Hepatitis B virus surface antigen, recombinant (HBsAg)* 5 micrograms. Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+).
* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.
This vaccine may contain traces of formaldehyde and potassium thiocyanate, which are used during the manufacturing process. See sections 4.3, 4.4 and 4.8.
Excipient(s) with known effect: Sodium less than 1 mmol (23 mg) per dose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hepatitis B, purified antigen |
Hepatitis B vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg). Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer. |
| List of Excipients |
|---|
|
Sodium chloride |
0.5 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps. Pack size of 1, 10.
0.5 ml of suspension in vial (glass) with stopper (gray butyl rubber) and aluminum seals with plastic flip caps with an empty sterile injection syringe with needle. Pack size of 1.
Not all pack sizes may be marketed.
MSD VACCINS, 162 avenue Jean Jaurès, 69007, Lyon, France
EU/1/01/183/001
EU/1/01/183/018
EU/1/01/183/019
Date of first authorisation: 27/04/2001
Date of last renewal: 17/03/2011
| Drug | Countries | |
|---|---|---|
| HBVAXPRO | Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom |
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