Maci

Expired

This medicine's authorisation has expired

matrix-applied characterised autologous cultured chondrocytes

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Assessment Report (EPAR) for MACI is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Maci : EPAR - Summary for the public

Reference Number: EMA/282918/2013

Product information

Maci : EPAR - Product Information

Maci : EPAR - All Authorised presentations

Maci : EPAR - Conditions for lifting the suspension of the marketing authorisation : Article-20 procedure - Annex II

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

Changes since initial authorisation of medicine

Maci : EPAR - Procedural steps taken and scientific information after authorisation

Maci : EPAR - Scientific Conclusion : Article-20 procedure - Annex I

Initial marketing authorisation documents

Maci : EPAR - Public assessment report : Article-20 procedure

Adopted Reference Number: EMA/671958/2014

Maci : EPAR - Public assessment report

Adopted Reference Number: EMA/25287/2013

CHMP summary of positive opinion for Maci

Adopted Reference Number: EMA/54023/2013