Medicines studied at Cetero Research facility

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision
Current status:
European Commission final decision

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
  • Cilazapril Teva
  • Fenofibrato Pensa
  • Fenofibrato Ranbaxy
  • Leflunomide Actavis
  • Leflunomide Apotex
Class
-
Reference number
EMEA/H/A-31/001340
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
13/12/2012
EC decision date
20/02/2013

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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