ChondroCelect

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

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The marketing authorisation for Chondrocelect has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
ChondroCelect : EPAR - Summary for the public BG = bălgarski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public ES = español 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public CS = čeština 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public DA = dansk 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public DE = Deutsch 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public ET = eesti keel 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public EL = elliniká 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public EN = English 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public FR = français 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public IT = italiano 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public LV = latviešu valoda 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public LT = lietuvių kalba 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public HU = magyar 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public MT = Malti 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public NL = Nederlands 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public PL = polski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public PT = português 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public RO = română 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public SK = slovenčina 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public SL = slovenščina 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public FI = suomi 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public SV = svenska 2009-11-16 2016-08-04
ChondroCelect : EPAR - Summary for the public HR = Hrvatski 2009-11-16 2016-08-04

This EPAR was last updated on 04/08/2016 .

Authorisation details

Product details

Product details for ChondroCelect
NameChondroCelect
Agency product numberEMEA/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 Cartilage Diseases
Anatomical therapeutic chemical (ATC) code M09AX02

Publication details

Publication details for ChondroCelect
Marketing-authorisation holder

TiGenix N.V.

Revision6
Date of issue of marketing authorisation valid throughout the European Union05/10/2009

Contact address:

TiGenix N.V.
Romeinse straat 12/2
B-3001 Leuven
Belgium

Product information

Product information

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

Name Language First published Last updated
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Product Information HR = Hrvatski 2009-11-16 2016-08-04

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.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - All Authorised presentations HR = Hrvatski 2009-11-16 2016-08-04

Name Language First published Last updated
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04
ChondroCelect : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-11-16 2016-08-04

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

Changes since initial authorisation of medicine

Name Language First published Last updated
ChondroCelect : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2011-10-21 2016-08-04

Initial marketing-authorisation documents

Name Language First published Last updated
ChondroCelect : EPAR - Public assessment report HR = Hrvatski 2009-11-16 2016-09-14
Committee for medicinal products for human use summary of positive opinion for ChondroCelect HR = Hrvatski 2009-06-25 2016-08-04

Authorised

This medicine is approved for use in the European Union

More information on Chondrocelect