ChondroCelect
characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Table of contents
Overview
The marketing authorisation for Chondrocelect has been withdrawn at the request of the marketing-authorisation holder.
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
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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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Pharmacotherapeutic group
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.