• Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status
European Commission final decision


Nimesulide is a non-steroidal anti-inflammatory drug (NSAID).
Nimesulide containing medicinal products are currently marketed in more than 50 countries worldwide. In Europe, nimesulide is nationally authorised in 10 Member States: Austria, Belgium, Finland, France, Greece, Ireland, Italy, Luxembourg, Portugal and Spain. The first launch was in Italy in 1985. The multitude of national Marketing Authorisations granted at different points in time has lead to divergence in the approved therapeutic indications, posology, recommended duration of treatment in the European Community.

Following the granting of marketing authorisations of nimesulide containing products in Finland (January 1998), cases of hepatic adverse reactions, ranging from asymptomatic increases in liver enzymes to hepatic failure that required liver transplant, have been reported. By 13 March 2002, the Finnish National Agency for Medicines had received altogether 109 Adverse Drug Reaction reports concerning nimesulide, of these 66 were hepatic reactions, including serious reactions (e.g. hepatitis,hepatic failure, including two cases necessitating liver transplantation). Based on these serious hepatic reactions and taking into account the relatively non-serious conditions for which nimesulide is indicated for as well as the existence of numerous alternative treatments, the Marketing Authorisations of nimesulide containing medicinal products for oral administration have been suspended in Finland on 18 March 2002.

On 10 April 2002, Finland notified the CPMP and EMEA Secretariat of a referral under Article 31 of Directive 2001/83/EC as amended, requesting the CPMP to give its opinion on the risk-benefit balance of all nimesulide containing medicinal products, especially in view of the hepatic toxicity.

Furthermore, on 3 May 2002, Spain circulated a Rapid Alert about the suspension of the marketing of nimesulide containing medicinal products in their territory.

The Marketing Authorisation Holders/Applicants provided written explanations by 10 September 2002. Supplementary information was provided by 3 February 2003, 6 June 2003 and 11 July 2003. Oral explanations were given by the Marketing Authorisation Holders/Applicants on 25 June 2003.

Upon consideration of all available data, the CPMP adopted an opinion on 24 July 2003. On 21 October 2003, the European Commission returned the Opinion back to the CPMP for further consideration of its recommendation as regards to the 200 mg tablets. Therefore, the CPMP adopted a revised opinion on 17 December 2003. This revised opinion recommended the maintenance of the Marketing Authorisations for nimesulide containing medicinal products as amended and/or the granting of Marketing Authorisations in accordance with the Summaries of Product Characteristics as set out in Annex III, for all medicinal products listed in Annex I. In accordance with the CPMP assessment of the efficacy data provided by the MAHs/Applicants and with the CPMP recommendations on the maximum oral posology of 100 mg twice a day, the CPMP CPMP/1724 /04 concluded that the efficacy of the oral dosage of 200 mg twice-a-day is not supported; in consequence the Marketing Authorisations of the 200 mg tablets have been withdrawn and Marketing Authorisations for the 200 mg tablet should not be granted. In addition, the opinion contained certain conditions concerning post-marketing data and communication as set out in Annex IV.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics in Annex III and the conditions of the Marketing Authorisations in Annex IV.

On the basis of the CPMP Opinion, the European Commission issued a Decision on 26 April 2004.

Notes: The information given in this document and Annexes reflect only the CPMP Opinion dated 17 December 2003. The Member States competent authorities will continue to keep the product under regular review.

Key facts

About this medicine
Approved name
International non-proprietary name (INN) or common name
About this procedure
Current status
European Commission final decision
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.

Key dates and outcomes
CHMP opinion date
EC decision date

All documents

  • List item

    Nimesulide - Article 31 referral - Annex III (PDF/246.11 KB)


    First published: 13/05/2004
    Last updated: 13/05/2004

  • 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.

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