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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.

Key facts

Approved name
International non-proprietary name (INN) or common name
Reference number
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.

European Commission final decision
Opinion date
EC decision 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 taken for the marketing authorisation(s) such as safety measures or extra studies

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