Inductos
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
On 22 October 2015, the European Medicines Agency (EMA) recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures. Inductos will remain suspended until issues with the manufacturing site for one of the components of Inductos (an absorbable sponge) are resolved.
EMA started a review of Inductos following an inspection by Dutch and Spanish authorities which found the manufacturing site of the absorbable sponge to be non-compliant with manufacturing requirements. The inspectors noted that the manufacturer, located in the United States, did not have adequate measures in place to prevent particle contamination of the sponges.
Although there is no indication of risk to patients linked to the inspection findings, EMA's Committee for Medicinal Products for Human Use (CHMP) considered that the quality of Inductos cannot be assured with the current manufacturing process. The CHMP therefore concluded that Inductos should be suspended until the manufacturing issues are satisfactorily addressed.
The CHMP recommendation was sent to the European Commission, which endorsed it and issued a final legally binding decision.
Key facts
| Approved name |
Inductos
|
| International non-proprietary name (INN) or common name |
dibotermin alfa |
| Associated names |
Inductos
|
| Reference number |
EMEA/H/A-20/1422/C/0408/0082
|
| 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 |
22/10/2015
|
| EC decision date |
20/11/2015
|
All documents
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List item
Inductos Article-20 procedure - Inductos to be suspended in the EU (PDF/80.05 KB)
First published: 23/10/2015
Last updated: 07/12/2015
EMA/683814/2015 -
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Inductos Article-20 procedure - Assessment report (PDF/114.58 KB)
First published: 07/12/2015
Last updated: 07/12/2015
EMA/746527/2015 -
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Inductos Article-20 procedure - Annex I (PDF/50.95 KB)
First published: 07/12/2015
Last updated: 07/12/2015 -
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Inductos Article-20 procedure - Annex II (PDF/29.42 KB)
First published: 07/12/2015
Last updated: 07/12/2015 -
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Inductos Article-20 procedure - Review started (PDF/75.47 KB)
Adopted
First published: 24/07/2015
Last updated: 24/07/2015
EMA/491454/2015 -
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Inductos Article-20 procedure - CHMP list of questions (PDF/72.62 KB)
Adopted
First published: 24/07/2015
Last updated: 24/07/2015
EMA/CHMP/492625/2015 -
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Inductos Article-20 procedure - Notification (PDF/224.51 KB)
First published: 24/07/2015
Last updated: 24/07/2015 -
List item
Inductos Article-20 procedure – Timetable for the procedure (PDF/79.39 KB)
First published: 24/07/2015
Last updated: 29/09/2015
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:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 201523/10/2015
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23/10/2015
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24/07/2015
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24/07/2015