- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Cisapride is a prokinetic active substance belonging to the pharmacotherapeutic group of propulsives.
It has been authorised nationally in the EU Member States for the treatment of a variety of motilityrelated gastrointestinal disorders since 1988.
On 29 June 2000, Germany presented a referral to the EMEA under Article 31 of Directive 2001/83/EC (previously Article 12 of Council Directive 75/319/EEC). Germany considered that the use of cisapride containing medicinal products raised concerns as it might exert a substantial QT-prolonging action leading to potentially life-threatening cardiac arrythmia.
The Marketing Authorisation Holders provided written explanations by 4 September 2000, and supplementary information by 5 March 2001, 02 July 2001, 24 September 2001 and 23 November 2001. Oral explanations were given by the Marketing Authorisation Holders on 25 April 2001 and 13 November 2001.
Upon consideration of all available data, the CPMP adopted an opinion on 13 December 2001. This opinion recommended the maintenance of the Marketing Authorisations for cisapride containing medicinal products listed in Annex I but restricting the use of these medicinal products, with subsequent amendments to the Summary of Product Characteristics (SPC) set out in Annex III. It should be noted however, that Marketing Authorisations for Cisapride containing medicinal products could only be maintained, if their SPCs were in line with the amended SPCs, presented in Annex III to the CPMP Opinion on Cisapride. As a consequence, the Cisapride Marketing Authorisations for 30 mg suppositories and 20 mg tablets, dispersible tablets, oral lyophilisate and lozenges, listed in Annex I to the Opinion, which are not in line with the CPMP recommendation on the use of Cisapride as reflected in the amended SPCs cannot be maintained, as they concern a different pharmaceutical form or a different strength.
In addition, the opinion contains certain conditions set out in Annex IV such as inclusion of treated patients in either a clinical trial, a safety study or a registry program, to be applied to Marketing Authorisations for cisapride containing medicinal products.
The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II, together with the amended Summary of Product Characteristics in the Annex III and the conditions of the marketing authorisations in the Annex IV.
On the basis of the CPMP Opinion, the European Commission issued a Decision on 30 May 2002.
Opinion following an Article 31 referral for Cisapride International Non-Proprietary Name (INN): Cisapride: Background information and Annexes I, II and IV (English) and Annex III (all languages) (PDF/364.18 KB)Adopted
First published: 08/10/2002
Last updated: 08/10/2002
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||
Opinion following an Article 31 referral for Cisapride International Non-Proprietary Name (INN): Cisapride: Background information and Annexes I, II and IV (English) and Annex III (all languages) (PDF/364.18 KB)
First published: 08/10/2002
Last updated: 08/10/2002
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.