Xeomin

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Xeomin, 100 LD50 units powder for solution for injection, is indicated for the symptomatic management of blepharospasm and cervical dystonia of a predominantly rotational form (spasmodic torticollis) in adults.

Merz Pharmaceuticals GmbH submitted applications for mutual recognition of Xeomin, 100 LD50 units powder for solution for injection, on the basis of the marketing authorisation granted by Germany on 31 May 2005. The Mutual Recognition Procedure started on 24 October 2006. The Reference Member State was Germany and the Concerned Member States were Austria, Denmark, Spain, Finland, France, Italy, Luxembourg, Norway, Poland, Portugal, Sweden and United Kingdom. These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State. Germany referred the reasons for disagreement to the EMEA on 29 March 2007.

On the basis of the questions raised by the Member States, the points to be considered by the CHMP concerned the posology, the repeated administration and safety profile in two Phase III studies.

The arbitration procedure started on 26 April 2007 with the adoption of a list of questions. The Rapporteur was Dr Karl Broich and Co-Rapporteur(s) was Dr Pierre Demolis. The Marketing Authorisation Holder provided written explanations on 25 May 2007.

During their 16-19 July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Xeomin, that the objections raised by Finland, France and Italy, should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended. A positive opinion was adopted by majority on 19 July 2007.

The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.

The final opinion was converted into a Decision by the European Commission on 24 October 2007.

Name Language First published Last updated
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information BG = bălgarski 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information ES = español 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information CS = čeština 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information DA = dansk 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information DE = Deutsch 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information ET = eesti keel 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information EL = elliniká 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information EN = English 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information FR = français 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information IT = italiano 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information LV = latviešu valoda 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information LT = lietuvių kalba 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information HU = magyar 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information MT = Malti 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information NL = Nederlands 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information PL = polski 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information PT = português 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information RO = română 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information SK = slovenčina 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information SL = slovenščina 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information FI = suomi 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information SV = svenska 25/10/2007  

Key facts

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

clostridium botulinum neurotoxin type A

Associated names
Class
Reference numberCHMP/350251/07
TypeArticle 29(4) referrals

This type of referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

StatusEuropean Commission final decision
Opinion date19/07/2007

All documents

Name Language First published Last updated
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information BG = bălgarski 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information ES = español 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information CS = čeština 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information DA = dansk 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information DE = Deutsch 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information ET = eesti keel 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information EL = elliniká 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information EN = English 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information FR = français 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information IT = italiano 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information LV = latviešu valoda 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information LT = lietuvių kalba 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information HU = magyar 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information MT = Malti 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information NL = Nederlands 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information PL = polski 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information PT = português 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information RO = română 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information SK = slovenčina 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information SL = slovenščina 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information FI = suomi 25/10/2007  
Opinion following an Article 29(4) referral for Xeomin International Non-Proprietary Name (INN): Clostridium botulinum neurotoxin type A: Background information SV = svenska 25/10/2007  
Xeomin - Article 29 referral - Annex I, II, III BG = bălgarski 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III ES = español 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III DA = dansk 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III DE = Deutsch 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III ET = eesti keel 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III EL = elliniká 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III EN = English 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III FR = français 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III IT = italiano 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III LV = latviešu valoda 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III LT = lietuvių kalba 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III HU = magyar 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III MT = Malti 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III NL = Nederlands 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III PL = polski 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III PT = português 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III RO = română 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III SK = slovenčina 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III SL = slovenščina 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III FI = suomi 07/02/2008  
Xeomin - Article 29 referral - Annex I, II, III SV = svenska 07/02/2008  

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