Xefo

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Xefo and associated names, 4mg and 8mg film-coated tablets, 8mg rapid film coated tablet, and 8mg powder and solvent for solution for injection, is a non-steroidal anti-inflammatory drug (NSAID), used for short-term relief of acute mild to moderate pain, symptomatic relief of pain and inflammation in osteoarthritis and symptomatic relief of pain and inflammation in rheumatoid arthritis.

On 16 May 2006 Nycomed Denmark Aps presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Package Leaflets and Labelling of the medicinal product Xefo and associated names.

The basis for referral was that there were divergences in the Summaries of Product Characteristics of Xefo and associated names approved across EU Member States, with respect to the short-term relief of acute mild to moderate pain, symptomatic relief of pain and inflammation in osteoarthritis and symptomatic relief of pain and inflammation in rheumatoid arthritis.

The procedure started on 2 June 2006. The Marketing Authorisation Holder provided supplementary information on 21 September 2006 and 12 January 2007.

During its February 2007 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package leaflet was acceptable and that they should be amended.

The CHMP gave a positive opinion on 22 February 2007 recommending the harmonisation of the SPC, labelling and package leaflet for Xefo and associated names.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, labelling and package leaflet in Annex III.

A Decision was issued by the European Commission on 29 May 2007.

Name Language First published Last updated
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information BG = bălgarski 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information ES = español 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information CS = čeština 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information DA = dansk 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information DE = Deutsch 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information ET = eesti keel 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information EL = elliniká 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information EN = English 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information FR = français 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information IT = italiano 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information LV = latviešu valoda 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information LT = lietuvių kalba 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information HU = magyar 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information MT = Malti 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information NL = Nederlands 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information PL = polski 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information PT = português 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information RO = română 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information SK = slovenčina 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information SL = slovenščina 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information FI = suomi 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information SV = svenska 29/05/2007  

Key facts

Approved nameXefo
International non-proprietary name (INN) or common name

lornoxicam

Associated names
Class
Reference numberCHMP/144030/07
TypeArticle 30 referrals

This type of referral is triggered when Member States have adopted different decisions over the years for some medicines (e.g. different indications, contraindications or posology) and there is a need to harmonise across the European Union.

StatusEuropean Commission final decision
Opinion date22/02/2007

All documents

Name Language First published Last updated
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information BG = bălgarski 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information ES = español 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information CS = čeština 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information DA = dansk 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information DE = Deutsch 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information ET = eesti keel 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information EL = elliniká 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information EN = English 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information FR = français 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information IT = italiano 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information LV = latviešu valoda 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information LT = lietuvių kalba 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information HU = magyar 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information MT = Malti 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information NL = Nederlands 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information PL = polski 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information PT = português 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information RO = română 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information SK = slovenčina 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information SL = slovenščina 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information FI = suomi 29/05/2007  
Opinion following an Article 30 referral for Xefo and associated names International Non-proprietary Name (INN): lornoxicam: Background information SV = svenska 29/05/2007  
Xefo - Article 30 referral - Annex I, II, III BG = bălgarski 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III ES = español 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III CS = čeština 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III DA = dansk 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III DE = Deutsch 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III ET = eesti keel 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III EL = elliniká 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III EN = English 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III FR = français 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III IT = italiano 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III LV = latviešu valoda 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III LT = lietuvių kalba 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III HU = magyar 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III MT = Malti 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III NL = Nederlands 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III PL = polski 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III PT = português 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III RO = română 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III SK = slovenčina 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III SL = slovenščina 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III FI = suomi 28/09/2007  
Xefo - Article 30 referral - Annex I, II, III SV = svenska 28/09/2007  

Document description

  • 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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision