Havrix - referral

Current status

Under evaluation

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.

More about the medicine

Havrix is a vaccine that contains inactivated (killed) hepatitis A virus; it can be used in children and adults to protect against hepatitis A infection. Havrix is authorised in all EU Member States with the exception of Croatia, plus Norway and Iceland. 

More about the procedure

The review of Havrix and associated names has been initiated at the request of the marketing authorisation holder, GlaxoSmithKline Biologicals SA, under Article 30 of Directive 2001/83/EC.

The review is being carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency’s opinion. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU and EEA Member States.

Havrix - Article 30 referral - Review started

Reference Number: EMA/404824/2023

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:
  Under evaluation
• 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

All documents

Procedure started

Havrix - Article 30 referral - Timetable for the procedure

Reference Number: EMA/CHMP/101583/2023 rev.3

Havrix - Article 30 referral - Annex I

Reference Number: EMA/415457/2023

Havrix - Article 30 referral - Notification

Havrix - Article 30 referral - Review started

Reference Number: EMA/404824/2023

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.