ChondroCelect

RSS

characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Chondrocelect has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 12/01/2017

Authorisation details

Product details
Name
ChondroCelect
Agency product number
EMEA/H/C/000878
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
Publication details
Marketing-authorisation holder
TiGenix N.V.
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
05/10/2009
Contact address
Romeinse straat 12/2
B-3001 Leuven
Belgium

Product information

29/07/2016 ChondroCelect - EMEA/H/C/000878 - IAIN/012/G

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

Please note that the size of the above document can exceed 50 pages.

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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.

Assessment history

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