Pharmaceuticals - Community Register

  

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: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M09 - Other drugs for disorders of the musculo-skeletal system
Pharmacological subgroup: M09A - Other drugs for disorders of the musculo-skeletal system
Chemical subgroup: M09AX - Other drugs for disorders of the musculo-skeletal system
Chemical substance: 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

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 proceduresGoto top of the page

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
11/11/2013 Centralised - Variation EMEA/H/C/878/IA/7