Maci

matrix-applied characterised autologous cultured chondrocytes

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The marketing authorisation for Maci has been suspended at the recommendation of the  Agency's Committee for Medicinal Products for Human Use (CHMP).

Name Language First published Last updated
Maci : EPAR - Summary for the public BG = bălgarski 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public ES = español 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public CS = čeština 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public DA = dansk 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public DE = Deutsch 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public ET = eesti keel 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public EL = elliniká 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public EN = English 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public FR = français 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public IT = italiano 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public LV = latviešu valoda 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public LT = lietuvių kalba 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public HU = magyar 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public MT = Malti 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public NL = Nederlands 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public PL = polski 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public PT = português 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public RO = română 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public SK = slovenčina 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public SL = slovenščina 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public FI = suomi 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public SV = svenska 12/07/2013 17/12/2014
Maci : EPAR - Summary for the public HR = Hrvatski 12/07/2013 17/12/2014

This EPAR was last updated on 13/06/2016 .

Authorisation details

Product details

Product details for Maci
NameMaci
Agency product numberEMEA/H/C/002522
Active substance

autologous cultured chondrocytes

International non-proprietary name (INN) or common name

matrix-applied characterised autologous cultured chondrocytes

Therapeutic area Fractures, Cartilage
Anatomical therapeutic chemical (ATC) code M09AX02
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Maci
Marketing-authorisation holder

Vericel Denmark ApS

Revision3
Date of issue of marketing authorisation valid throughout the European Union27/06/2013

Contact address:

Vericel Denmark ApS
Amaliegade 10,
DK-1256 Copenhagen K
Denmark

Product information

Product information

17/09/2015  Maci -EMEA/H/C/002522 -IAIN/0009

Name Language First published Last updated
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016
Maci : EPAR - Product Information HR = Hrvatski 12/07/2013 13/06/2016

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
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - All Authorised presentations HR = Hrvatski 12/07/2013 17/12/2014

Name Language First published Last updated
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  
Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II HR = Hrvatski 17/12/2014  

Pharmacotherapeutic group

Other medicines for disorders of the musculoskeletal system

Therapeutic indication

Repair of symptomatic cartilage defects of the knee.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Maci : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 17/09/2014 13/06/2016
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  
Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I HR = Hrvatski 17/12/2014  

Initial marketing-authorisation documents

Name Language First published Last updated
Maci : EPAR - Public assessment report HR = Hrvatski 12/07/2013 17/12/2014
Maci : EPAR - Public assessment report : Article-20 procedure HR = Hrvatski 17/12/2014  
CHMP summary of positive opinion for Maci HR = Hrvatski 26/04/2013 17/12/2014

Suspended

This medicine is currently suspended for use in the European Union

More information on Maci

  • Maci (Closure of EU manufacturing site for MACI)

 

Shortages