- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
On 25 September 1996, Germany presented a referral for chlormezanone under Article 12 of Council Directive 75/319/EEC as amended. Germany requested the CPMP “to give an opinion on whether there is an unfavourable benefit/risk relation for chlormezanone in the indication where it is most widely used in the EU, that is lower back pain with muscle contracture”.
According to the CPMP opinion given on 22 January 1997, the risk/benefit balance of chlormezanone-containing compounds was considered to be unfavourable, and the Committee recommended the withdrawal of the marketing authorisations of all chlormezanone-containing medicinal products.
Some of the Marketing Authorisation Holders of chlormezanone appealed against the opinion and grounds for appeal were submitted on 21 March 1997.
On 14 May 1997, the CPMP having considered the grounds for appeal adopted a final opinion maintaining the conclusions of the opinion dated 22 January 1997.
A copy of the final opinion for chlormezanone is provided on the Internet, together with Annex C which provides the scientific conclusions. Translations of the opinion and Annex C, are also provided on the Internet in French, German, and Spanish.
The final opinion was converted into a Decision by the European Commission on 27 August 1997.
About this medicine
|International non-proprietary name (INN) or common name||
About this procedure
European Commission final decision
Article 31 referrals
This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.
Key dates and outcomes
|CHMP opinion date||
|EC decision date||
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.