Maci

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Expired

This medicine's authorisation has expired

matrix-applied characterised autologous cultured chondrocytes
MedicineHumanExpired
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for MACI (matrix applied characterised autologous cultured chondrocytes) expired on 1 July 2018 following the decision of the marketing authorisation holder, Vericel Denmark ApS, not to pursue the renewal of the marketing authorisation. 

MACI was granted marketing authorisation in the European Union (EU) on 27 June 2013 as an implant used to repair cartilage defects in the knee joint. The marketing authorisation for MACI had been suspended since 19 November 2014 due to the absence of an authorised manufacturing site for the finished product, active substance and batch release. The suspension had not been lifted prior to the expiry of the marketing authorisation. 

The European Public Assessment Report (EPAR) for MACI is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: IAIN/0009
01/07/2018
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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Product details

Name of medicine
Maci
Active substance
autologous cultured chondrocytes
International non-proprietary name (INN) or common name
matrix-applied characterised autologous cultured chondrocytes
Therapeutic area (MeSH)
Fractures, Cartilage
Anatomical therapeutic chemical (ATC) code
M09AX02

Pharmacotherapeutic group

Other drugs for disorders of the musculo-skeletal system

Therapeutic indication

Repair of symptomatic cartilage defects of the knee.

Authorisation details

EMA product number
EMEA/H/C/002522

Advanced therapy

This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

Marketing authorisation holder
Vericel Denmark ApS

Amaliegade 10,
DK-1256 Copenhagen K
Denmark

Marketing authorisation issued
27/06/2013
Expiry of marketing authorisation
01/07/2018
Revision
4

Assessment history

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