collagenase Clostridium histolyticum

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Xiapex. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xiapex.

This EPAR was last updated on 10/01/2020

Authorisation details

Product details
Agency product number
Active substance
collagenase Clostridium histolyticum
International non-proprietary name (INN) or common name
collagenase Clostridium histolyticum
Therapeutic area (MeSH)
Dupuytren Contracture
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Swedish Orphan Biovitrum AB
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Tomtebodavagen 23A
SE-112 76 Stockholm

Product information

28/11/2019 Xiapex - EMEA/H/C/002048 - PSUSA/00000871/201902


  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Other drugs for disorders of the musculoskeletal system

Therapeutic indication

Xiapex is indicated for:

  • The treatment of Dupuytren’s contracture in adult patients with a palpable cord.
  • The treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

Assessment history

Changes since initial authorisation of medicine

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