Infanrix HepB

Application under evaluation
CHMP opinion
European Commission decision

Overview

On 25 April 2005 the European Commission adopted the decision withdrawing the Marketing Authorisation for the medicinal product for human use Infanrix HepB. It followed the notification by the Marketing Authorisation Holder (GlaxoSmithKline Biologicals) to voluntarily withdraw the Marketing Authorisation for Infanrix HepB for marketing reasons.

The MAH confirmed that this decision was based on commercial reasons and not due to any safety related concerns. Infanrix HepB [diphtheria toxoid, tetanus toxoid, acellular pertussis components (pertussis toxoid, filamentous haemagglutinin and pertactin), recombinant hepatitis B surface antigen (r-HBsAg)], was indicated for active immunization of all infants from the age of 2 months against diphtheria, tetanus, pertussis and hepatitis B.

It should be noted that there are other Community Marketing Authorisation valid throughout the European Union which contain the same antigens, i.e. diphtheria toxoid, tetanus toxoid, acellular pertussis, recombinant hepatitis B surface antigen (r-HBsAg). As a consequence to this decision the European Public Assessment Report for Infanrix HepB has been removed from this website.

Product information

25/04/2005

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).

Product details

Name of medicine

Infanrix HepB

Active substance

Diphtheria toxoid
tetanus toxoid
pertussis toxoid
pertussis haemagglutin filamentous
pertactin
hepatitis B recombinant surface antigen

International non-proprietary name (INN) or common name

diphtheria, tetanus, acellular pertussis and hepatitis B recombinant, adsorbed vaccine

Therapeutic area (MeSH)

Hepatitis B
Tetanus
Immunization
Whooping Cough
Diphtheria

Anatomical therapeutic chemical (ATC) code

J07CA

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Infanrix HepB is indicated for active immunisation of all infants from the age of 2 months against
diphtheria, tetanus, pertussis and hepatitis B.

Authorisation details

EMA product number: EMEA/H/C/000126
Marketing authorisation holder: GlaxoSmithKline Biologicals S.A.
Rue de l'Institut, 89
B-1330 Rixensart
Belgium
Marketing authorisation issued: 30/07/1997
Revision: 3

This page was last updated on 04/08/2005

Withdrawn