Xiapex

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Withdrawn

This medicine's authorisation has been withdrawn

collagenase Clostridium histolyticum
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 5 December 2019, the European Commission withdrew the marketing authorisation for Xiapex (collagenase Clostridium histolyticum) in the European Union (EU). The withdrawal is effective as of 1 March 2020. The withdrawal was at the request of the marketing authorisation holder, Swedish Orphan Biovitrum AB (publ), which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Xiapex was granted marketing authorisation in the EU on 28 February 2011 for treatment of Dupuytren’s contracture/ Peyronie’s disease in adult patients. 

The European Public Assessment Report (EPAR) for Xiapex is updated to indicate that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information:PSUSA/00000871/201902
28/11/2019
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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).

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svenska (SV) (574.35 KB - PDF)

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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 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.

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

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