- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
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.
|International non-proprietary name (INN) or common name||
influenza vaccine, purified antigen
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 This referral has been replaced by Articles 107i and 31.
European Commission final decision
|EC decision date||
Questions and answers on the review of Preflucel and associated names (influenza vaccine, purified antigen) (PDF/76.34 KB)Adopted
First published: 20/07/2012
Last updated: 20/07/2012
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.