- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
The European Medicines Agency (EMEA) has completed a review of the benefits and risks of etoricoxib-containing medicines. The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of etoricoxib-containing medicines outweigh their risks when used to treat rheumatoid arthritis (an immune system disease causing inflammation of the joints) or ankylosing spondylitis (a disease causing inflammation and pain in the joints of the spine). However, a number of measures need to be introduced into the prescribing information for these medicines, to minimise the risks associated with their use. This review was carried out under 'Article '6(12)'1 and 'Article 31' referrals2.
1 Article 6(12) of Commission Regulation EC No 1083/2003, arbitration procedure initiated by a Member State following disagreement between Member States on a type II variation.
2 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
3 Etoricoxib is available in Algix, Arcoxia, Auxib, Etoricoxib MSD, Exxiv, Ranacox, Tauxib and Turox.
|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
Questions and answers on the review of etoricoxib-containing medicines (PDF/38.79 KB)Adopted
First published: 26/06/2008
Last updated: 26/06/2008
Opinion following an Article 31(2) referral for Etoricoxib containing medicinal products International Non-Proprietary Name (INN): etoricoxib: Background information (PDF/35.48 KB)Adopted
First published: 23/10/2008
Last updated: 23/10/2008
Etoricoxib - Article 31 referral - Annex I, II, III (PDF/221.81 KB)Adopted
First published: 21/11/2008
Last updated: 21/11/2008
- 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