Xiapex

Withdrawn

This medicine's authorisation has been withdrawn

collagenase Clostridium histolyticum

Overview

The marketing authorisation for Xiapex has been withdrawn at the request of the marketing-authorisation holder.

Xiapex : EPAR - Summary for the public

Reference Number: EMEA/H/C/002048

Product information

Xiapex : EPAR - Product Information

Latest procedure affecting product information: PSUSA/00000871/201902

28/11/2019

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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

AdoptedReference Number: EMA/CHMP/349968/2015

CHMP post-authorisation summary of positive opinion for Xiapex

AdoptedReference Number: EMA/CHMP/747440/2014

Initial marketing authorisation documents

Xiapex : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Xiapex

AdoptedReference Number: EMA/CHMP/773322/2010