Xiapex

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collagenase Clostridium histolyticum

Authorised
This medicine is authorised for use in the European Union.

Overview

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 12/12/2017

Authorisation details

Product details
Name
Xiapex
Agency product number
EMEA/H/C/002048
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
Publication details
Marketing-authorisation holder
Swedish Orphan Biovitrum AB
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
28/02/2011
Contact address
Tomtebodavagen 23A
SE-112 76 Stockholm
Sweden

Product information

08/12/2017 Xiapex - EMEA/H/C/002048 - PSUSA/00000871/201702

Contents

  • 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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