Havrix

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision

Table of contents

Current status
Procedure started

Overview

The European Medicines Agency (EMA) has started a review of Havrix and associated names, a vaccine used to protect adults and children against hepatitis A virus infection. The vaccine contains the inactivated (killed) hepatitis A virus and cannot cause the disease.

Havrix has been authorised in the EU via national procedures. This has led to inconsistency across Member States in the way the vaccine can be used, as seen in the differences in the prescribing information (summaries of product characteristics, labelling and package leaflets) in the countries where the vaccine is available.

EMA will consider the available data on Havrix and will amend the prescribing information to harmonise the way Havrix is used in the EU.

The amended information for doctors and patients will be available on the EMA website once the review has concluded.

Key facts

About this medicine
Approved name
Havrix
International non-proprietary name (INN) or common name
hepatitis A virus (inactivated, adsorbed)
Associated names
Havrix and associated names
About this procedure
Current status
Procedure started
Reference number
EMEA/H/A-30/1527
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.
Authorisation model
Nationally authorised product(s)
Decision making model
CHMP-EC
Key dates and outcomes
CHMP opinion date
14/09/2023

All documents

Procedure started

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.

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