HBVAXPRO Suspension for injection Ref.[9864] Active ingredients: Hepatitis B, purified antigen

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: MSD VACCINS, 162 avenue Jean Jaurรจs, 69007, Lyon, France

Product name and form

HBVAXPRO 5 micrograms, suspension for injection.

Hepatitis B vaccine (recombinant DNA).

Pharmaceutical Form

Suspension for injection.

Slightly opaque white suspension.

Qualitative and quantitative composition

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
Borax
Water for injections

Pack sizes and marketing

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.

Marketing authorization holder

MSD VACCINS, 162 avenue Jean Jaurรจs, 69007, Lyon, France

Marketing authorization dates and numbers

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

Drugs

Drug Countries
HBVAXPRO Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom

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