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Opinion provided by Committee for Medicinal Products for Human Use


On 19 July 2012, the European Medicines Agency (EMA) completed a review of the seasonal influenza vaccine Preflucel, following an increase in the number of reported suspected side effects including hypersensitivity (allergic) reactions, which led to a recall of Preflucel batches from the European Union (EU) market. The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the likely cause has been identified and that a number of corrective measures should be integrated into the manufacturing process to resolve the problem.

Key facts

Approved name
International non-proprietary name (INN) or common name
influenza vaccine, purified antigen
Reference number
Article 36 referrals (prior to July 2012)

This type of referral applied for a marketing authorisation that were granted via the mutual-recognition or decentralised procedure. It was triggered when a Member State considered that action (variation, suspension or withdrawal) was needed on the grounds of the need to protect public health. This referral has been replaced by Articles 107i and 31.

Opinion provided by Committee for Medicinal Products for Human Use
Opinion date

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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