Pharmaceuticals - Community Register

  

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: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M09 - Other drugs for disorders of the musculo-skeletal system
Pharmacological subgroup: M09A - Other drugs for disorders of the musculo-skeletal system
Chemical subgroup: M09AB - Enzymes
Chemical substance: M09AB02 - Collagenase clostridium histolyticum
(See WHO ATC Index)
Indication: Treatment of Dupuytren´s contracture in adult patients with a palpable cord.
Marketing Authorisation Holder: Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm, Sverige

  EPAR and active package presentations

Package presentations

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 is 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
10/06/2013 Centralised - Variation EMEA/H/C/2048/IAin/22
Updated with Decision(2014)2344 of 03/04/2014
31/10/2013 Centralised - Notification EMEA/H/C/2048/N/27
Updated with Decision(2014)2344 of 03/04/2014
12/12/2013 Centralised - Variation EMEA/H/C/2048/IA/20
Updated with Decision(2014)2344 of 03/04/2014
10/01/2014 Centralised - Variation EMEA/H/C/2048/IA/33
Updated with Decision(2014)2344 of 03/04/2014
07/04/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2048/T/37 (2014)2344 of 03/04/2014
26/06/2014 Centralised - Variation EMEA/H/C/2048/II/38
26/06/2014 Centralised - Variation EMEA/H/C/2048/IAin/43
30/07/2014 Centralised - Variation EMEA/H/C/2048/IB/48