Medicines studied at Cetero Research facility

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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.

Which medicines are affected by the Agency's review?

The Agency's review covers the following centrally authorised medicines, whose marketing authorisation applications included studies conducted at the Cetero Research facility in Houston, Texas, United States:

  • Ribavirin Teva and Ribavirin Teva Pharma B.V., generic medicines containing ribavirin, used for the treatment of hepatitis C (a disease of the liver due to an infection with the hepatitis-C virus);
  • Temodal, an anticancer medicine containing temozolomide, used for the treatment of malignant glioma (brain tumours);
  • Tygacil, an antibiotic containing tigecycline, used for the treatment of complicated infections of the skin and soft tissue (the tissue below the skin), and complicated infections in the abdomen.

In addition, the Agency reviewed the following nationally authorised medicines, whose marketing-authorisation applications also included studies conducted at this Cetero Research facility:

  • Cilazapril Teva, a generic medicine containing cilazapril, used for the treatment of hypertension (high blood pressure) and heart failure (when the heart does not work as well as it should);
  • Fenofibrato Pensa and Fenofibrato Ranbaxy, generic medicines containing fenofibrate, used to control the levels of cholesterol and other lipids (fats) in the blood;
  • Leflunomide Actavis and Leflunomide Apotex, generic medicines containing the active substance leflunomide, used for the treatment of rheumatoid arthritis (an immune system disease causing damage and inflammation in the joints).

In July 2012, the CHMP concluded a similar review for three other concerned centrally authorised medicines: Conbriza, PecFent and Torisel.

Why were these medicines reviewed?

The Agency was made aware that recent inspections of the Texas-based Cetero Research facility by the United States Food and Drug Administration had raised concerns over the way laboratory analyses of certain studies, called ‘bio-analytical’ studies, were conducted at this facility in the period from April 2005 to June 2010. Hence, the results of the studies concerned could not be considered reliable.

In total, seven centrally authorised medicines and five nationally authorised medicines were identified whose marketing-authorisation applications included data from studies conducted at this Cetero Research facility.

Consequently, the European Commission asked the CHMP to assess whether the identified issues have an impact on the benefit-risk balance of the centrally authorised medicines concerned, and to issue an opinion on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the European Union (EU). In addition, the United Kingdom medicines regulatory agency requested the CHMP to carry out the same assessment for the nationally authorised medicines concerned.

Which data has the CHMP reviewed?

The CHMP reviewed the bio-analytical studies performed at Texas-based Cetero Research facility that had been submitted as part of the marketing-authorisation applications of the medicines concerned. The Committee considered the importance of the data from these studies in the context of the overall data submitted in the applications. The CHMP also requested the companies to provide any additional relevant data, which had not been submitted as part of the initial applications.

What are the conclusions of the CHMP?

Cilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex, Ribavirin Teva and Ribavirin Teva Pharma B.V.

For these generic medicines, the studies conducted at the Texas-based Cetero Research facility were bioequivalence studies, to demonstrate that they produce the same levels of the active substance in the body as their reference medicines. Although the Committee noted that no problems have been identified with the products currently on the market, bioequivalence studies are a mandatory part of the marketing-authorisation application for generic medicines. As the results of these studies could not be considered reliable, the CHMP concluded that the marketing authorisation of these medicines should be suspended until the companies provide adequate data.

During a re-examination procedure for Fenofibrato Pensa and Fenofibrato Ranbaxy, the company submitted new data, which is not permitted in the context of a re-examination. The CHMP confirmed its previous conclusions on these medicines.

Temodal

The CHMP noted that the studies conducted at this facility were two studies submitted in support of the approval of Temodal solution for infusion. The Committee concluded that the data from these studies were confirmed by other studies conducted elsewhere, and therefore that there is no impact on the benefit-risk balance of Temodal and no further action is needed.

Tygacil

The Committee noted that the studies conducted at this facility do not support any indication or prescribing recommendation for Tygacil. One of the studies is a ‘pharmacokinetic’ study in children, whose results are included in the product information. However, as Tygacil is not approved for use in this population, no specific action was considered necessary. Nevertheless the CHMP requested the company to update the product information with revised data.

In July 2012, the CHMP had already completed a similar review of three other medicines (Conbriza, PecFent and Torisel) and concluded that there is no impact on the benefit-risk balance of these medicines and that the marketing authorisation should be maintained.

What are the recommendations for patients and prescribers?
  • Patients and prescribers should note that there are no safety concerns with any of these medicines currently on the market.
  • Patients who are taking any of the generic medicines that have been suspended should be aware that alternative treatments are available.
  • Patients who have any questions should speak to their doctor or pharmacist.

The European Commission issued decisions on:

  • Temodal: 26 November 2012;
  • Leflunomide Actavis and associated names: 30 November 2012;
  • Leflunomide Apotex and associated names: 30 November 2012;
  • Tygacil: 30 November 2012;
  • Ribavirin Teva: 6 December 2012;
  • Ribavirin Teva Pharma B.V: 6 December 2012;
  • Cilazapril Teva and associated names: 10 December 2012;
  • Fenofibrato Pensa and Fenofibrato Ranbaxy: 20 February 2013.

 

Name Language First published Last updated
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility BG = bălgarski 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility ES = español 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility CS = čeština 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility DA = dansk 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility DE = Deutsch 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility ET = eesti keel 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility EL = elliniká 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility EN = English 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility FR = français 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility IT = italiano 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility LV = latviešu valoda 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility LT = lietuvių kalba 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility HU = magyar 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility MT = Malti 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility NL = Nederlands 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility PL = polski 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility PT = português 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility RO = română 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility SK = slovenčina 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility SL = slovenščina 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility FI = suomi 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility SV = svenska 14/12/2012 12/03/2013

Key facts

Approved nameMedicines studied at Cetero Research facility
International non-proprietary name (INN) or common name

fenofibrate, cilazapril, leflunomide

Associated namesCilazapril Teva, Fenofibrato Pensa, Fenofibrato Ranbaxy, Leflunomide Actavis, Leflunomide Apotex
Class-
Reference numberEMEA/H/A-31/001340
TypeArticle 31 referrals

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

StatusEuropean Commission final decision
Opinion date13/12/2012

All documents

Name Language First published Last updated
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility BG = bălgarski 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility ES = español 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility CS = čeština 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility DA = dansk 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility DE = Deutsch 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility ET = eesti keel 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility EL = elliniká 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility EN = English 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility FR = français 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility IT = italiano 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility LV = latviešu valoda 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility LT = lietuvių kalba 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility HU = magyar 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility MT = Malti 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility NL = Nederlands 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility PL = polski 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility PT = português 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility RO = română 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility SK = slovenčina 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility SL = slovenščina 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility FI = suomi 14/12/2012 12/03/2013
Questions and answers on the review of medicines for which studies have been conducted at Texas-based Cetero Research facility SV = svenska 14/12/2012 12/03/2013
Assessment report for Cilazapril Teva (English only) 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I BG = bălgarski 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I ES = español 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I CS = čeština 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I DA = dansk 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I DE = Deutsch 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I ET = eesti keel 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I EL = elliniká 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I EN = English 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I FR = français 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I IT = italiano 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I LV = latviešu valoda 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I LT = lietuvių kalba 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I HU = magyar 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I MT = Malti 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I NL = Nederlands 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I PL = polski 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I PT = português 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I RO = română 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I SK = slovenčina 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I SL = slovenščina 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I FI = suomi 12/03/2013  
Cilazapril Teva Article-31 referral - Annex I SV = svenska 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II BG = bălgarski 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II ES = español 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II CS = čeština 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II DA = dansk 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II DE = Deutsch 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II ET = eesti keel 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II EL = elliniká 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II EN = English 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II FR = français 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II IT = italiano 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II LV = latviešu valoda 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II LT = lietuvių kalba 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II HU = magyar 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II MT = Malti 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II NL = Nederlands 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II PL = polski 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II PT = português 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II RO = română 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II SK = slovenčina 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II SL = slovenščina 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II FI = suomi 12/03/2013  
Cilazapril Teva Article-31 referral - Annex II SV = svenska 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III BG = bălgarski 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III ES = español 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III CS = čeština 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III DA = dansk 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III DE = Deutsch 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III ET = eesti keel 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III EL = elliniká 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III EN = English 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III FR = français 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III IT = italiano 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III LV = latviešu valoda 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III LT = lietuvių kalba 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III HU = magyar 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III MT = Malti 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III NL = Nederlands 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III PL = polski 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III PT = português 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III RO = română 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III SK = slovenčina 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III SL = slovenščina 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III FI = suomi 12/03/2013  
Cilazapril Teva Article-31 referral - Annex III SV = svenska 12/03/2013  
Assessment report for Leflunomide Actavis (English only) 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I BG = bălgarski 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I ES = español 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I CS = čeština 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I DA = dansk 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I DE = Deutsch 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I ET = eesti keel 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I EL = elliniká 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I EN = English 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I FR = français 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I IT = italiano 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I LV = latviešu valoda 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I LT = lietuvių kalba 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I HU = magyar 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I MT = Malti 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I NL = Nederlands 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I PL = polski 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I PT = português 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I RO = română 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I SK = slovenčina 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I SL = slovenščina 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I FI = suomi 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex I SV = svenska 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II BG = bălgarski 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II ES = español 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II CS = čeština 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II DA = dansk 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II DE = Deutsch 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II ET = eesti keel 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II EL = elliniká 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II EN = English 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II FR = français 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II IT = italiano 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II LV = latviešu valoda 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II LT = lietuvių kalba 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II HU = magyar 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II MT = Malti 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II NL = Nederlands 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II PL = polski 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II PT = português 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II RO = română 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II SK = slovenčina 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II SL = slovenščina 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II FI = suomi 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex II SV = svenska 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III BG = bălgarski 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III ES = español 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III CS = čeština 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III DA = dansk 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III DE = Deutsch 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III ET = eesti keel 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III EL = elliniká 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III EN = English 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III FR = français 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III IT = italiano 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III LV = latviešu valoda 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III LT = lietuvių kalba 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III HU = magyar 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III MT = Malti 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III NL = Nederlands 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III PL = polski 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III PT = português 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III RO = română 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III SK = slovenčina 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III SL = slovenščina 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III FI = suomi 12/03/2013  
Leflunomide Actavis Article-31 referral - Annex III SV = svenska 12/03/2013  
Assessment report for Leflunomide Apotex (English only) 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I BG = bălgarski 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I ES = español 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I CS = čeština 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I DA = dansk 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I DE = Deutsch 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I ET = eesti keel 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I EL = elliniká 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I EN = English 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I FR = français 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I IT = italiano 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I LV = latviešu valoda 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I LT = lietuvių kalba 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I HU = magyar 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I MT = Malti 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I NL = Nederlands 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I PL = polski 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I PT = português 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I RO = română 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I SK = slovenčina 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I SL = slovenščina 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I FI = suomi 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex I SV = svenska 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II BG = bălgarski 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II ES = español 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II CS = čeština 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II DA = dansk 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II DE = Deutsch 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II ET = eesti keel 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II EL = elliniká 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II EN = English 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II FR = français 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II IT = italiano 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II LV = latviešu valoda 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II LT = lietuvių kalba 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II HU = magyar 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II MT = Malti 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II NL = Nederlands 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II PL = polski 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II PT = português 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II RO = română 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II SK = slovenčina 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II SL = slovenščina 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II FI = suomi 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex II SV = svenska 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III BG = bălgarski 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III ES = español 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III CS = čeština 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III DA = dansk 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III DE = Deutsch 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III ET = eesti keel 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III EL = elliniká 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III EN = English 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III FR = français 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III IT = italiano 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III LV = latviešu valoda 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III LT = lietuvių kalba 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III HU = magyar 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III MT = Malti 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III NL = Nederlands 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III PL = polski 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III PT = português 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III RO = română 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III SK = slovenčina 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III SL = slovenščina 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III FI = suomi 12/03/2013  
Leflunomide Apotex Article-31 referral - Annex III SV = svenska 12/03/2013  
Assessment report for Fenofibrato Pensa and Fenofibrato Ranbaxy (English only) 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I BG = bălgarski 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I ES = español 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I CS = čeština 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I DA = dansk 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I DE = Deutsch 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I ET = eesti keel 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I EL = elliniká 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I EN = English 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I FR = français 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I IT = italiano 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I LV = latviešu valoda 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I LT = lietuvių kalba 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I HU = magyar 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I MT = Malti 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I NL = Nederlands 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I PL = polski 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I PT = português 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I RO = română 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I SK = slovenčina 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I SL = slovenščina 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex I FI = suomi 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II BG = bălgarski 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II ES = español 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II CS = čeština 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II DA = dansk 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II DE = Deutsch 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II ET = eesti keel 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II EL = elliniká 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II EN = English 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II FR = français 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II IT = italiano 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II LV = latviešu valoda 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II LT = lietuvių kalba 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II HU = magyar 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II MT = Malti 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II NL = Nederlands 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II PL = polski 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II PT = português 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II RO = română 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II SK = slovenčina 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II SL = slovenščina 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex II FI = suomi 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III BG = bălgarski 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III ES = español 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III CS = čeština 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III DA = dansk 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III DE = Deutsch 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III ET = eesti keel 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III EL = elliniká 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III EN = English 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III FR = français 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III IT = italiano 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III LV = latviešu valoda 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III LT = lietuvių kalba 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III HU = magyar 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III MT = Malti 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III NL = Nederlands 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III PL = polski 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III PT = português 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III RO = română 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III SK = slovenčina 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III SL = slovenščina 12/03/2013  
Fenofibrato Pensa and Fenofibrato Ranbaxy Article-31 referral - Annex III FI = suomi 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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

More information on medicines studied at Cetero Research facility