ChondroCelect

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Withdrawn

This medicine's authorisation has been withdrawn

characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 29 July 2016, the European Commission withdrew the marketing authorisation for ChondroCelect (characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins) in the European Union (EU), which will become effective as of 30 November 2016. The withdrawal was at the request of the marketing authorisation holder, TiGenix NV, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

ChondroCelect was granted marketing authorisation in the EU on 5 October 2009 for repair of single symptomatic cartilaginous defects. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2014. 

The European Public Assessment Report (EPAR) for ChondroCelect is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: IAIN/012/G
29/07/2016
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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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Product details

Name of medicine
ChondroCelect
Active substance
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
International non-proprietary name (INN) or common name
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Therapeutic area (MeSH)
Cartilage Diseases
Anatomical therapeutic chemical (ATC) code
M09AX02

Pharmacotherapeutic group

Other drugs for disorders of the musculo-skeletal system

Therapeutic indication

Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.

Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present. Demonstration of efficacy is based on a randomised controlled trial evaluating the efficacy of Chondrocelect in patients with lesions between 1 and 5 cm².

Authorisation details

EMA product number
EMEA/H/C/000878

Advanced therapy

This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

Marketing authorisation holder
TiGenix N.V.

Romeinse straat 12/2
B-3001 Leuven
Belgium

Marketing authorisation issued
05/10/2009
Withdrawal of marketing authorisation
29/07/2016
Revision
6

Assessment history

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