Maci
- Procedure started
- Under evaluation
- CAT draft opinion
- CHMP opinion
- European Commission final decision
Table of contents
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 Consequently, the licence of the manufacturing site was withdrawn.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
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About this medicine
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|
|---|---|
| Approved name |
Maci
|
| International non-proprietary name (INN) or common name |
matrix applied characterised autologous cultured chondrocytes
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| Associated names |
Maci
|
| Class |
Advanced therapies
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|
About this procedure
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|---|---|
| Current status |
European Commission final decision
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| Reference number |
EMEA/H/A20/1409/C/002522/0004
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| 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. |
| Decision making model |
CAT-CHMP-EC
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Key dates and outcomes
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|
|---|---|
| CHMP opinion date |
25/09/2014
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| EC decision date |
19/11/2014
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All documents
Opinion provided by Committee for Medicinal Products for Human Use
European Commission final decision
Maci Article-20 procedure - Assessment report (PDF/1.05 MB)
First published: 17/12/2014
Last updated: 17/12/2014
EMA/671958/2014
Maci Article-20 procedure - Annex I (PDF/1.36 MB)
First published: 17/12/2014
Last updated: 17/12/2014
Maci Article-20 procedure - Annex II (PDF/921.53 KB)
First published: 17/12/2014
Last updated: 17/12/2014
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.