HBVaxPro
hepatitis B vaccine (recombinant DNA)
Table of contents
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.
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 (recombinant DNA)
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J07BC01
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
| Revision |
32
|
| Date of issue of marketing authorisation valid throughout the European Union |
27/04/2001
|
| Contact address |
Waarderweg 39 |
Product information
15/08/2022 HBVaxPro - EMEA/H/C/000373 - IG1524/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.