Medicines studied at Cetero Research facility
- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
On 20 September 2012, the European Medicines Agency completed a review of nine centrally and nationally authorised medicines, following concerns over the conduct of laboratory analyses of certain studies submitted as part of their marketing-authorisation applications. The studies concerned were all conducted at the Cetero Research facility in Houston, Texas, United States.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that for seven medicines (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.) some of the studies that supported their authorisation could not be considered reliable. In the absence of reliable data, the CHMP recommended that their marketing authorisation should be suspended until adequate data are provided. For Temodal and Tygacil, the findings have no impact on the benefit-risk balance of these medicines and no further action is needed.
At the request of the company that markets Fenofibrato Pensa and Fenofibrato Ranbaxy, the CHMP re-examined the initial opinion for these medicines, and confirmed its previous recommendation on 13 December 2012.
Key facts
Approved name |
Medicines studied at Cetero Research facility
|
International non-proprietary name (INN) or common name |
fenofibrate, cilazapril, leflunomide |
Associated names |
|
Class |
-
|
Reference number |
EMEA/H/A-31/001340
|
Type | |
Status |
European Commission final decision
|
Opinion date |
13/12/2012
|
EC decision date |
20/02/2013
|
All documents
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Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility (PDF/63.64 KB)
First published: 14/12/2012
Last updated: 12/03/2013
EMA/796016/2012 Rev 1 -
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Assessment report for Cilazapril Teva (PDF/105.47 KB)
Adopted
First published: 12/03/2013
Last updated: 12/03/2013
EMA/691537/2012 -
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Cilazapril Teva Article-31 referral - Annex I (PDF/47.71 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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Cilazapril Teva Article-31 referral - Annex II (PDF/39.92 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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Cilazapril Teva Article-31 referral - Annex III (PDF/16.15 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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Assessment report for Leflunomide Actavis (PDF/98.88 KB)
Adopted
First published: 12/03/2013
Last updated: 12/03/2013
EMA/691568/2012 -
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Leflunomide Actavis Article-31 referral - Annex I (PDF/31.23 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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Leflunomide Actavis Article-31 referral - Annex II (PDF/34.98 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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Leflunomide Actavis Article-31 referral - Annex III (PDF/16.3 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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Assessment report for Leflunomide Apotex (PDF/112.86 KB)
Adopted
First published: 12/03/2013
Last updated: 12/03/2013
EMA/691570/2012 -
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Leflunomide Apotex Article-31 referral - Annex I (PDF/27.53 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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Leflunomide Apotex Article-31 referral - Annex II (PDF/47.47 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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Leflunomide Apotex Article-31 referral - Annex III (PDF/16.62 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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Assessment report for Fenofibrato Pensa and Fenofibrato Ranbaxy (PDF/100.48 KB)
Adopted
First published: 12/03/2013
Last updated: 12/03/2013
EMA/20843/2013 -
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Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I (PDF/20.45 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II (PDF/34.23 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III (PDF/17.76 KB)
First published: 12/03/2013
Last updated: 12/03/2013 -
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