Engerix B

Current status:
European Commission final decision

Overview

The active substance of Engerix B is a purified recombinant hepatitis B surface antigen, which is a noninfectious substance that protects adults and infants from hepatitis B by stimulating an immune response (immunogenic activity) against these diseases. There are two strengths of Engerix B 10 and 20 μg.The 20 μg dose (in 1.0 ml suspension) is intended for use in adults and children older than 15 years of age whereas the 10 μg dose (in 0.5-ml suspension) is intended for use in children up to and including 15 years of age, including neonates. The two strengths 10 and 20 μg are registered in all Member States of the European Union, except in the Netherlands where only the 20 μg strength is available.

National licenses were originally granted to the company SmithKline Beecham, for Engerix B vaccine in all 15 EU Member States. From these registrations and the subsequent variations, different Summaries of Product Characteristics (SPC) have been issued, based on national, divergent decisions. The differences in the SPC text relate to several sections: Therapeutic indication, Posology and method of administration, Special warning and special precautions for use, Interactions, Undesirable effects, Pharmacodynamic properties and List of excipients of the SPC.

On 7 October 1999, SmithKline Beecham Biologicals S.A acting on behalf of the all Marketing Authorisation Holders of each Member State presented to the EMEA a referral under Article 11 of Council Directive 75/319/EEC as amended, in order to harmonise the Summaries of Product Characteristics within the Member States. A proposal of Summary of Product Characteristics based on an updated dossier was provided.

The referral procedure started on 22 October 1999. The basis for this arbitration procedure was a harmonisation of the Summaries of Product Characteristics. The CPMP having considered the Rapporteur and the Co-Rapporteur assessment reports, Scientific discussion within the Committee and comments from the Marketing Authorisation Holders, was of the opinion that the benefit/risk ratio of Engerix B is favourable for the agreed indications and the above mentioned sections of the SPC. The CPMP issued a positive opinion, on 13 April 2000, recommending the harmonisation of the Summaries of Product Characteristics for Engerix B.

An overall summary of the scientific evaluation is provided, together with the amended Summaries of Product Characteristics.

A Decision was issued by the European Commission on 28 August 2000.

Key facts

Approved name
Engerix B
International non-proprietary name (INN) or common name
recombinant hepatitis B vaccine
Reference number
CPMP/1493/01
Type
Article 30 referrals

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the EU.

Status
European Commission final decision
Opinion date
13/04/2000
EC decision date
28/08/2000

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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