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Community Register of medicinal products

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Xiapex   
Auth. number : EU/1/11/671
INN : collagenase clostridium histolyticum
ATC: M - Musculo-skeletal system
M09 - Other drugs for disorders of the musculo-skeletal system
M09A - Other drugs for disorders of the musculo-skeletal system
M09AB - Enzymes
M09AB02 - Collagenase clostridium histolyticum
(See WHO ATC Index)
Indication: Treatment of Dupuytren´s contracture in adult patients with a palpable cord.
Marketing Authorisation Holder: Auxilium UK Limited
Orchard Lea, Winkfield Lane, Windsor, Berks SL4 4RU, United Kingdom

  EPAR and active package presentations

Package presentations

The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
01/03/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2048 (2011)1494 of 28/02/2011
02/03/2011 Centralised - Authorisation EMEA/H/C/2048 (2011)1493 of 28/02/2011
17/01/2013 Centralised - Variation EMEA/H/C/2048/II/16
Updated with Decision(2013)2103 of 09/04/2013
11/04/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2048/T/21 (2013)2103 of 09/04/2013