Maci

Current status:
European Commission final decision

Overview

Closure of EU manufacturing site

Arrangements in place for existing patients to complete their treatment

On 5 September 2014, the marketing authorisation holder for the advanced therapy medicine MACI (matrix applied characterised autologous cultured chondrocytes) closed the EU manufacturing site for the medicine, which is located in Denmark. Consequently, the licence of the manufacturing site was withdrawn. MACI is unavailable for new patients in the EU until a new manufacturing site has been registered in the EU. The closure was due to commercial reasons and the safety and effectiveness of MACI has not changed.

The European Medicines Agency has been working with the marketing authorisation holder since June 2014 to ensure that patients who had already started the treatment procedure were able to complete their treatment. A letter was sent to healthcare professionals informing them of the site closure and requesting that they notify the marketing authorisation holder of those patients who wish to complete their treatment. In addition, surgeons were asked not to start new patients on MACI.

Following the closure of the site, the marketing authorisation holder has been requested to store any remaining biopsies that have not yet been used to allow for potential later treatment with MACI, unless patients and their treating surgeons have explicitly indicated that they do not wish to complete treatment with MACI.

Key facts

Approved name
Maci
International non-proprietary name (INN) or common name
matrix-applied characterised autologous cultured chondrocytes
Associated names
Maci
Class
Advanced therapies
Reference number
EMEA/H/A20/1409/C/002522/0004
Type
Article 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

Status
European Commission final decision
Opinion date
25/09/2014
EC decision date
19/11/2014

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

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