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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | ChondroCelect
|
| Auth. number : | EU/1/09/563 |
| INN : | Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins |
| ATC: | M - Musculo-skeletal system M09 - Other drugs for disorders of the musculo-skeletal system M09A - Other drugs for disorders of the musculo-skeletal system M09AX - Other drugs for disorders of the musculo-skeletal system M09AX02 - Chondrocytes, autologous (See WHO ATC Index) |
| 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 1-5cm². |
| Marketing Authorisation Holder: | TiGenix NV
Romeinse straat 12/2, B-3001 Leuven, België |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information". Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which continues to be available in the Community Register. |
European Commission procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 06/10/2009 | Centralised - Authorisation - Decision addressed to Member States | EMEA/H/C/878 | (2009)7727 of 05/10/2009 | |||
| 07/10/2009 | Centralised - Authorisation | EMEA/H/C/878 | (2009)7726 of 05/10/2009 | |||
| 02/03/2011 | Centralised - Variation | EMEA/H/C/878/II/1 | ||||
| 29/09/2011 | Centralised - Variation | EMEA/H/C/878/IA/3/G | ||||
| Updated with Decision(2012)408 of 20/01/2012 | ||||||
| 24/01/2012 | Centralised - Variation | - | (2012)408 of 20/01/2012 | |||
| 29/05/2012 | Centralised - Variation | EMEA/H/C/878/IB/4 | ||||
| Updated with Decision(2012)7674 of 24/10/2012 | ||||||
| 26/10/2012 | Centralised - Variation | EMEA/H/C/878/II/6 | (2012)7674 of 24/10/2012 |