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

About this medicine
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
-
About this procedure
Current status
European Commission final decision
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.

Key dates and outcomes
CHMP opinion date
13/12/2012
EC decision date
20/02/2013

All documents

Opinion provided by Committee for Medicinal Products for Human Use

European Commission final decision

  • List item

    Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II (PDF/34.23 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • List item

    Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III (PDF/17.76 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • List item

    Assessment report for Cilazapril Teva (PDF/105.47 KB)

    Adopted

    First published: 12/03/2013
    Last updated: 12/03/2013
    EMA/691537/2012

  • List item

    Cilazapril Teva Article-31 referral - Annex I (PDF/47.71 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • List item

    Cilazapril Teva Article-31 referral - Annex II (PDF/39.92 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • List item

    Cilazapril Teva Article-31 referral - Annex III (PDF/16.15 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • List item

    Assessment report for Leflunomide Actavis (PDF/98.88 KB)

    Adopted

    First published: 12/03/2013
    Last updated: 12/03/2013
    EMA/691568/2012

  • List item

    Leflunomide Actavis Article-31 referral - Annex I (PDF/31.23 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • List item

    Leflunomide Actavis Article-31 referral - Annex II (PDF/34.98 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • List item

    Leflunomide Actavis Article-31 referral - Annex III (PDF/16.3 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • List item

    Assessment report for Leflunomide Apotex (PDF/112.86 KB)

    Adopted

    First published: 12/03/2013
    Last updated: 12/03/2013
    EMA/691570/2012

  • List item

    Leflunomide Apotex Article-31 referral - Annex I (PDF/27.53 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • List item

    Leflunomide Apotex Article-31 referral - Annex II (PDF/47.47 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • List item

    Leflunomide Apotex Article-31 referral - Annex III (PDF/16.62 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • List item

    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

  • List item

    Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I (PDF/20.45 KB)


    First published: 12/03/2013
    Last updated: 12/03/2013

  • 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.

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