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Product information

Invented name: MACI   
Auth. number : EU/1/13/847
Active substance : Matrix applied characterised autologous cultured chondrocytes
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: MACI is indicated for the repair of symptomatic, full-thickness cartilage defects of the knee (grade III and IV of the Modified Outerbridge Scale) of 3-20 cm2 in skeletally mature adult patients.
Marketing Authorisation Holder: Aastrom Biosciences DK ApS
Oliefabriksvej 45, 2770 Kastrup, Danmark
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 is 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
01/07/2013 Centralised - Authorisation EMEA/H/C/2522 (2013)4190 of 27/06/2013
28/08/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2522/T/3 (2014)6203 of 26/08/2014
24/11/2014 Referral EMEA/H/C/2522 (2014)8918 of 19/11/2014