- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
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.
Summary information on a referral opinion following an arbitration pursuant to Article 11 of Council Directive 75/319/EEC as amended for Engerix B - common Name: recombinant hepatitis B vaccine: Background information an... (PDF/23.66 KB)Adopted
First published: 28/08/2000
Last updated: 28/08/2000
About this medicine
|International non-proprietary name (INN) or common name||
hepatitis B recombinant vaccine, adsorbed
About this procedure
European Commission final decision
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.
Key dates and outcomes
|CHMP opinion date||
|EC decision date||
Summary information on a referral opinion following an arbitration pursuant to Article 11 of Council Directive 75/319/EEC as amended for Engerix B - common Name: recombinant hepatitis B vaccine: Background information an... (PDF/23.66 KB)
First published: 28/08/2000
Last updated: 28/08/2000
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.