- 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
- 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 takenfor the marketing authorisation(s) such as safety measures or extra studies