Xiapex

RSS

collagenase Clostridium histolyticum

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Xiapex has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 02/03/2020

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
20
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

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

Contents

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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.

Assessment history

Changes since initial authorisation of medicine

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