Xiapex
collagenase Clostridium histolyticum
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Xiapex has been withdrawn at the request of the marketing-authorisation holder.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
This medicine’s product information is available in all official EU languages.
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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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Pharmacotherapeutic group
Other drugs for disorders of the musculo-skeletal system
Therapeutic indication
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.