- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
The European Medicines Agency (EMEA) has recently completed a review of the safety of the non-steroidal anti-inflammatory drug (NSAID) piroxicam. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that piroxicam's benefits still outweigh its risks, but, based on safety grounds, only in certain, limited indications. In addition, the CHMP has concluded that piroxicam-containing medicines should no longer be used for the treatment of acute (short-term) pain and inflammation. The review was carried out under an 'Article 31' referral1.
As for all NSAIDs, piroxicam should always be used at the lowest dose for the shortest possible duration to control symptoms.
1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
|International non-proprietary name (INN) or common name||
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
|EC decision date||
Questions and answers on the review of Piroxicam (PDF/55.07 KB)Adopted
First published: 21/06/2007
Last updated: 21/06/2007
Committee for medicinal products for human use (CHMP) opinion following an Article 31(2) referral for Piroxicam containing medicinal products International Non-Proprietary Name (INN): piroxicam: Background information (PDF/21.31 KB)Adopted
First published: 20/09/2007
Last updated: 20/09/2007
Piroxicam - Article 31 referral - Annex I, II, III, IV (PDF/257.41 KB)Adopted
First published: 31/01/2008
Last updated: 31/01/2008
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.