- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
The COX-2 inhibitors celecoxib, etoricoxib, rofecoxib, parecoxib and valdecoxib, comprise a relatively new group of substances whose common pharmacological action is the selective inhibition of cyclooxygenase-2. COX-2 inhibitors have been introduced in medical practice for treatment of patients with chronic inflammatory degenerative diseases such as rheumatoid arthritis and osteoarthritis.
Rofecoxib and celecoxib have been first authorised in the EU for these indications, and subsequently rofecoxib for treatment of acute pain and pain due to primary dysmenorrhoea. Etoricoxib received later authorisation with similar indications in some EU-member states. Valdecoxib received a positive opinion for the rheumatic indications and primary dysmenorrhoea and was authorised in March 2003.Parecoxib, a prodrug of valdecoxib, was authorised in March 2002 for short-term treatment of postsurgical pain, when used intravenously or intramuscularly. Celecoxib received an authorisation in October 2003 in an orphan drug indication (familial adenomatous polyposis).
In July 2002, France notified the EMEA and submitted grounds for the referral under Article 31 of Council Directive 2001/83/EC as amended for medicinal products containing celecoxib, etoricoxib, rofecoxib, valdecoxib and parecoxib.
The CPMP, during its meeting held from 23 to 25 July 2002 decided to start a referral procedure under Article 31 of Directive 2001/83/EC as amended, for medicinal products containing celecoxib, etoricoxib, parecoxib, rofecoxib and valdecoxib. The questions identified related to gastrointestinal and cardiovascular safety. In October 2002, the CPMP asked additional questions relating to serious hypersensitivity reactions (anaphylaxis and angioedema) and serious skin reactions including Stevens- Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and exfoliative dermatitis in patients treated with COX-2 inhibitors.
The Marketing Authorisation Holders provided written explanations by 31 October 2002, and supplementary information by 30 April 2003 and by 15 August 2003. An oral explanation was given by the Marketing Authorisation Holders on 24 September 2003.
Upon consideration of all available data, the CPMP adopted an opinion on 20 November 2003, which was revised on 26 February 2004. This opinion recommended the maintenance of the Marketing Authorisations for celecoxib containing medicinal in the indications stated in the Summary of Product Characteristics as set out in Annex III.
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.
On the basis of the CPMP Opinion, the European Commission issued a Decision on 29 April 2004.
* Notes: The information given in this document and Annexes reflect only the CPMP Opinion dated 20 November 2003. The Member States competent authorities will continue to keep the product under regular review.
Opinion following an Article 31 referral for all medicinal products containing Celecoxib, Etoricoxib, Parecoxib, Rofecoxib or Valdecoxib International Non-Proprietary Name (INN): Etoricoxib: Background information (PDF/114.07 KB)Adopted
First published: 30/04/2004
Last updated: 30/04/2004
About this medicine
|International non-proprietary name (INN) or common name||
About this procedure
European Commission final decision
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||
Opinion following an Article 31 referral for all medicinal products containing Celecoxib, Etoricoxib, Parecoxib, Rofecoxib or Valdecoxib International Non-Proprietary Name (INN): Etoricoxib: Background information (PDF/114.07 KB)
First published: 30/04/2004
Last updated: 30/04/2004
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.