Xiapex

Withdrawn

This medicine's authorisation has been withdrawn

collagenase Clostridium histolyticum

Overview

On 5 December 2019, the European Commission withdrew the marketing authorisation for Xiapex (collagenase Clostridium histolyticum) in the European Union (EU). The withdrawal is effective as of 1 March 2020. The withdrawal was at the request of the marketing authorisation holder, Swedish Orphan Biovitrum AB (publ), which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Xiapex was granted marketing authorisation in the EU on 28 February 2011 for treatment of Dupuytren’s contracture/ Peyronie’s disease in adult patients. 

The European Public Assessment Report (EPAR) for Xiapex is updated to indicate that the marketing authorisation is no longer valid.

Xiapex : EPAR - Summary for the public

Reference Number: EMEA/H/C/002048

Product information

Xiapex : EPAR - Product Information

Xiapex : EPAR - All Authorised presentations

Xiapex : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

Product details

• Name of medicine:
  Xiapex
• 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:
  M09AB02

Pharmacotherapeutic group

Other drugs for disorders of the musculo-skeletal system

Therapeutic indication

• 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.

Authorisation details

• EMA product number:
  EMEA/H/C/002048
• Marketing authorisation holder:
  Swedish Orphan Biovitrum AB

  Tomtebodavagen 23A; SE-112 76 Stockholm; Sweden

• Marketing authorisation issued:
  28/02/2011
• Revision:
  20

Assessment history

Changes since initial authorisation of medicine

Xiapex : EPAR - Procedural steps taken and scientific information after authorisation

Xiapex-H-C-PSUSA-871-201902 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/694468/2019

Xiapex-H-C-PSUSA-871-201702 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/787779/2017

Xiapex-H-C-PSUSA-00000871-201502 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/816625/2015

Xiapex-H-C-PSUSA-0871-201402 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/207618/2015

Xiapex-H-C-2048-II-0044 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/349968/2015

CHMP post-authorisation summary of positive opinion for Xiapex

Adopted Reference Number: EMA/CHMP/747440/2014

Initial marketing authorisation documents

Xiapex : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Xiapex

Adopted Reference Number: EMA/CHMP/773322/2010