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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Xiapex has been withdrawn at the request of the marketing-authorisation holder.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 | |
Product information
28/11/2019 Xiapex - EMEA/H/C/002048 - PSUSA/00000871/201902
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
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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.