Referral: Havrix, hepatitis A virus (inactivated, adsorbed), associated names: Havrix and associated names, Article 30 referrals, Procedure started, 14/09/2023
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.
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