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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/847|
|INN :||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:||Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland
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.
|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|