- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Cerivastatin is an HMG CoA reductase inhibitor authorised in Europe through the Mutual Recognition system at doses of 0.1- 0.4mg for the treatment of hyperlipidaemia.
On 19 September 2001, Portugal notified the EMEA of a referral under Article 15a of Directive 75/319/EEC (now Article 36 of Directive 2001/83/EC) regarding all cerivastatin containing medicinal products approved under a Mutual Recognition procedure. Portugal requested that a full assessment of the risk-benefit of cerivastatin be carried out because of concerns regarding a possible increased risk of rhabdomyolysis.
The Procedure was started at the September 2001 CPMP meeting. Written explanations were provided by the Marketing Authorisation Holders on 23 October 2001 with supplementary information on 31 October 2001.
On 4 January 2002 the EMEA received a fax from Bayer announcing that they intended to withdraw all marketing authorisations for cerivastatin containing medicinal products by 15 January 2002 and would not seek to reintroduce cerivastatin. They requested that the Article 36 procedure be terminated. The CPMP discussed the request to terminate the Article 36 procedure at its January meeting. It was decided that there was still a public health issue to be resolved and decided to continue the procedure in line with section 4 of Chapter 3 of The Notice to Applicants Volume 2A.
On 14 February 2002 the EMEA received from Bayer the response to the List of Outstanding Issues.
An oral explanation to the CPMP took place on 20 March 2002. The CPMP adopted an Opinion on 21 March 2002 recommending the withdrawal of the Marketing Authorisation for cerivastatin containing medicinal products authorised under the Mutual Recognition Procedure.
The Scientific conclusions are provided in Annex II.
The final Opinion was converted into a Decision by the European Commission on 22 August 2002.
|International non-proprietary name (INN) or common name||
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 This referral has been replaced by Articles 107i and 31.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||
Opinion following an Article 36 referral for Cerivastatin International Non-Proprietary Name (INN): Cerivastatin: Background information (PDF/94.61 KB)Adopted
First published: 01/09/2002
Last updated: 01/09/2002
Cerivastatin - Article 36 referral - Annex I, II (PDF/214.65 KB)Adopted
First published: 20/12/2002
Last updated: 20/12/2002
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.