Xiapex
Withdrawn
This medicine's authorisation has been withdrawn
collagenase Clostridium histolyticum
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Xiapex has been withdrawn at the request of the marketing-authorisation holder.
Xiapex : EPAR - Summary for the public
Reference Number: EMEA/H/C/002048
English (EN) (671.95 KB - PDF)
First published: Last updated:
български (BG) (791.48 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
español (ES) (672 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
čeština (CS) (748.27 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
dansk (DA) (665.44 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Deutsch (DE) (674.54 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
eesti keel (ET) (665.96 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
ελληνικά (EL) (799.95 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
français (FR) (673.65 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
hrvatski (HR) (691.54 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
italiano (IT) (670.46 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
latviešu valoda (LV) (752.46 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
lietuvių kalba (LT) (697.65 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
magyar (HU) (741.89 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Malti (MT) (751.91 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Nederlands (NL) (670.19 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
polski (PL) (762.78 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
português (PT) (672.18 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
română (RO) (700.68 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
slovenčina (SK) (747.28 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
slovenščina (SL) (737.49 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Suomi (FI) (666.94 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
svenska (SV) (667.85 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Product information
Xiapex : EPAR - Product Information
English (EN) (1.56 MB - PDF)
First published: Last updated:
български (BG) (3.25 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
español (ES) (1.56 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
čeština (CS) (2.67 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
dansk (DA) (1.59 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Deutsch (DE) (1.63 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
eesti keel (ET) (1.52 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
ελληνικά (EL) (3.26 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
français (FR) (1.66 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
hrvatski (HR) (1.69 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
íslenska (IS) (1.54 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
italiano (IT) (1.66 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
latviešu valoda (LV) (2.77 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
lietuvių kalba (LT) (1.89 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
magyar (HU) (2.63 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Malti (MT) (2.8 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Nederlands (NL) (1.57 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
norsk (NO) (1.76 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
polski (PL) (2.77 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
português (PT) (1.61 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
română (RO) (1.89 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
slovenčina (SK) (2.69 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
slovenščina (SL) (2.57 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Suomi (FI) (1.59 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
svenska (SV) (1.57 MB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Latest procedure affecting product information:
PSUSA/00000871/201902
28/11/2019
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Xiapex : EPAR - All Authorised presentations
English (EN) (574.28 KB - PDF)
First published: Last updated:
български (BG) (625.92 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
español (ES) (574.39 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
čeština (CS) (617.94 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
dansk (DA) (574.33 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Deutsch (DE) (574.42 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
eesti keel (ET) (575.26 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
ελληνικά (EL) (625.22 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
français (FR) (572.88 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
íslenska (IS) (574.28 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
italiano (IT) (574.27 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
latviešu valoda (LV) (620.18 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
lietuvių kalba (LT) (602.55 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
magyar (HU) (602.29 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Malti (MT) (617.95 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Nederlands (NL) (574.32 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
norsk (NO) (597.86 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
polski (PL) (618.66 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
português (PT) (572.89 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
română (RO) (602.54 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
slovenčina (SK) (618.15 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
slovenščina (SL) (589.17 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Suomi (FI) (574.31 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
svenska (SV) (574.35 KB - PDF)
First published: 14/03/2011Last updated: 02/03/2020
Xiapex : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
English (EN) (831.5 KB - PDF)
First published: Last updated:
Product details
- Name of medicine
- Xiapex
- 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
Pharmacotherapeutic group
Other drugs for disorders of the musculo-skeletal systemTherapeutic 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.
Authorisation details
- EMA product number
- EMEA/H/C/002048
- Marketing authorisation holder
- Swedish Orphan Biovitrum AB
Tomtebodavagen 23A
SE-112 76 Stockholm
Sweden - Marketing authorisation issued
- 28/02/2011
- Revision
- 20
Assessment history
Xiapex : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (1.71 MB - PDF)
First published: Last updated:
Xiapex-H-C-PSUSA-871-201902 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/694468/2019
English (EN) (699.11 KB - PDF)
First published: Last updated:
Xiapex-H-C-PSUSA-871-201702 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/787779/2017
English (EN) (650.75 KB - PDF)
First published: Last updated:
Xiapex-H-C-PSUSA-00000871-201502 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/816625/2015
English (EN) (625.11 KB - PDF)
First published: Last updated:
Xiapex-H-C-PSUSA-0871-201402 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
Reference Number: EMA/CHMP/207618/2015
English (EN) (639.39 KB - PDF)
First published: Last updated:
Xiapex-H-C-2048-II-0044 : EPAR - Assessment Report - Variation
AdoptedReference Number: EMA/CHMP/349968/2015
English (EN) (8.67 MB - PDF)
First published: Last updated:
CHMP post-authorisation summary of positive opinion for Xiapex
AdoptedReference Number: EMA/CHMP/747440/2014
English (EN) (647.59 KB - PDF)
First published: Last updated:
News on Xiapex
More information on Xiapex
Public statement on Xiapex : Withdrawal of the marketing authorisation in the European Union
Reference Number: EMA/95504/2020
English (EN) (129.07 KB - PDF)
First published:
This page was last updated on