HBVaxPro

RSS

hepatitis-B vaccine (rDNA)

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for HBVaxPro. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for HBVaxPro.

This EPAR was last updated on 10/01/2018

Authorisation details

Product details
Name
HBVaxPro
Agency product number
EMEA/H/C/000373
Active substance
hepatitis B, recombinant surface antigen
International non-proprietary name (INN) or common name
hepatitis-B vaccine (rDNA)
Therapeutic area (MeSH)
  • Hepatitis B
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BC01
Publication details
Marketing-authorisation holder
MSD VACCINS
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
26/04/2001
Contact address
162 avenue Jean Jaurès
69007 Lyon
France

Product information

18/12/2017 HBVaxPro - EMEA/H/C/000373 - N/0060

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Vaccines

Therapeutic indication

5 micrograms

HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-B virus.

The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations.

It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection.

10 micrograms

HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-B virus.

The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations.

It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection.

40 micrograms

HBVaxPro is indicated for the active immunisation against hepatitis-B-virus infection caused by all known subtypes in predialysis and dialysis adult patients.

It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

Assessment history

Changes since initial authorisation of medicine

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