Xiapex

collagenase Clostridium histolyticum

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Xiapex has been withdrawn at the request of the marketing-authorisation holder.

List item

Xiapex : EPAR - Summary for the public (PDF/671.95 KB)

First published: 14/03/2011
Last updated: 02/03/2020
EMEA/H/C/002048
- Bulgarian
  (PDF/791.48 KB)
- Croatian
  (PDF/691.54 KB)
- Czech
  (PDF/748.27 KB)
- Danish
  (PDF/665.44 KB)
- Dutch
  (PDF/670.19 KB)
- Estonian
  (PDF/665.96 KB)
- Finnish
  (PDF/666.94 KB)
- French
  (PDF/673.65 KB)
- German
  (PDF/674.54 KB)
- Greek
  (PDF/799.95 KB)
- Hungarian
  (PDF/741.89 KB)
- Italian
  (PDF/670.46 KB)
- Latvian
  (PDF/752.46 KB)
- Lithuanian
  (PDF/697.65 KB)
- Maltese
  (PDF/751.91 KB)
- Polish
  (PDF/762.78 KB)
- Portuguese
  (PDF/672.18 KB)
- Romanian
  (PDF/700.68 KB)
- Slovak
  (PDF/747.28 KB)
- Slovenian
  (PDF/737.49 KB)
- Spanish
  (PDF/672 KB)
- Swedish
  (PDF/667.85 KB)

More detail is available in the summary of product characteristics

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

List item

Xiapex : EPAR - Product Information (PDF/1.56 MB)

First published: 14/03/2011
Last updated: 02/03/2020
- Bulgarian
  (PDF/3.25 MB)
- Croatian
  (PDF/1.69 MB)
- Czech
  (PDF/2.67 MB)
- Danish
  (PDF/1.59 MB)
- Dutch
  (PDF/1.57 MB)
- Estonian
  (PDF/1.52 MB)
- Finnish
  (PDF/1.59 MB)
- French
  (PDF/1.66 MB)
- German
  (PDF/1.63 MB)
- Greek
  (PDF/3.26 MB)
- Hungarian
  (PDF/2.63 MB)
- Icelandic
  (PDF/1.54 MB)
- Italian
  (PDF/1.66 MB)
- Latvian
  (PDF/2.77 MB)
- Lithuanian
  (PDF/1.89 MB)
- Maltese
  (PDF/2.8 MB)
- Norwegian
  (PDF/1.76 MB)
- Polish
  (PDF/2.77 MB)
- Portuguese
  (PDF/1.61 MB)
- Romanian
  (PDF/1.89 MB)
- Slovak
  (PDF/2.69 MB)
- Slovenian
  (PDF/2.57 MB)
- Spanish
  (PDF/1.56 MB)
- Swedish
  (PDF/1.57 MB)

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.

List item

Xiapex : EPAR - All Authorised presentations (PDF/574.28 KB)

First published: 14/03/2011
Last updated: 02/03/2020
- Bulgarian
  (PDF/625.92 KB)
- Czech
  (PDF/617.94 KB)
- Danish
  (PDF/574.33 KB)
- Dutch
  (PDF/574.32 KB)
- Estonian
  (PDF/575.26 KB)
- Finnish
  (PDF/574.31 KB)
- French
  (PDF/572.88 KB)
- German
  (PDF/574.42 KB)
- Greek
  (PDF/625.22 KB)
- Hungarian
  (PDF/602.29 KB)
- Icelandic
  (PDF/574.28 KB)
- Italian
  (PDF/574.27 KB)
- Latvian
  (PDF/620.18 KB)
- Lithuanian
  (PDF/602.55 KB)
- Maltese
  (PDF/617.95 KB)
- Norwegian
  (PDF/597.86 KB)
- Polish
  (PDF/618.66 KB)
- Portuguese
  (PDF/572.89 KB)
- Romanian
  (PDF/602.54 KB)
- Slovak
  (PDF/618.15 KB)
- Slovenian
  (PDF/589.17 KB)
- Spanish
  (PDF/574.39 KB)
- Swedish
  (PDF/574.35 KB)

List item

Xiapex : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/831.5 KB)

First published: 14/03/2011
Last updated: 02/03/2020

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

Initial marketing-authorisation documents

News

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 December 2014

19/12/2014

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Xiapex

Table of contents

Overview

Xiapex : EPAR - Summary for the public (PDF/671.95 KB)

Authorisation details

Product information

Xiapex : EPAR - Product Information (PDF/1.56 MB)

Contents

Xiapex : EPAR - All Authorised presentations (PDF/574.28 KB)

Xiapex : EPAR - Conditions imposed on member states for safe and effective use - Annex IV (PDF/831.5 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Xiapex : EPAR - Procedural steps taken and scientific information after authorisation (PDF/1.71 MB)

Xiapex-H-C-PSUSA-871-201902 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/699.11 KB)

Xiapex-H-C-PSUSA-871-201702 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/650.75 KB)

Xiapex-H-C-PSUSA-00000871-201502 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/625.11 KB)

Xiapex-H-C-PSUSA-0871-201402 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation (PDF/639.39 KB)

Xiapex-H-C-2048-II-0044 : EPAR - Assessment Report - Variation (PDF/8.67 MB)

CHMP post-authorisation summary of positive opinion for Xiapex (PDF/647.59 KB)

Initial marketing-authorisation documents

Xiapex : EPAR - Public assessment report (PDF/1.64 MB)

CHMP summary of positive opinion for Xiapex (PDF/625.76 KB)

News

More information on Xiapex

Public statement on Xiapex : Withdrawal of the marketing authorisation in the European Union (PDF/129.07 KB)

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