Tildren

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Tiludronic acid as the disodium salt, is a synthetic derivative of pyrophosphate belonging to the class of biphosphonates. TILDREN 500 mg, lyophilisate for solution for infusion is a veterinary medicinal product indicated as an aid in the treatment of clinical signs of lameness associated with bone spavin in combination with a controlled exercise regime in horses over 3 years of age. 

The marketing authorisation holder, CEVA Animal Health Ltd, submitted an application for a mutual recognition procedure for TILDREN 500 mg, lyophilisate for solution for infusion, on the basis of the marketing authorisation granted by the United Kingdom. The application was submitted in the framework of Article 32 of Directive 2001/82/EC, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia, Spain and Sweden. The Mutual Recognition Procedure UK/V/0321/001/MR started on 1 May 2008. 

On 4 November 2008, the United Kingdom, referred the matter to the Agency under Article 33(4) of Directive 2001/82/EC, due to concerns, raised by Belgium and Sweden, that the efficacy of the product has not been sufficiently demonstrated. 

The referral procedure started on 12 November 2008. The Rapporteur and Co-Rapporteur appointed were: Prof. Christian Friis and Dr Valda Sejane, respectively. Written explanations were provided by the Applicant on 16 February 2009. Oral explanations were given on 16 June 2009. 

Based on the evaluation of the rapporteurs’ assessment of the currently available data, the CVMP considered that the application does not satisfy the criteria for authorisation in respect of efficacy. Therefore, the Committee adopted an opinion on 15 July 2009 recommending the suspension of the existing marketing authorisation and the refusal of the granting of the marketing authorisations for Tildren 500 mg, lyophilisate for solution for infusion. 

On 5 August 2009, CEVA Animal Health Ltd notified the Agency of its intention to request a reexamination of the CVMP opinion of 15 July 2009. 

During its 15-17 September 2009 meeting, the CVMP appointed Dr David Murphy as rapporteur and Dr Jiří Bureš as co-rapporteur for the re-examination of the above mentioned opinion. 

The detailed grounds for the re-examination were submitted by  CEVA Animal Health Ltd on 21 September 2009 and the re-examination procedure started on 22 September 2009. 

Based on the evaluation of the rapporteurs’ assessment of the detailed grounds for the re-examination, on 11 November 2009, the CVMP considered the rapporteurs’ proposal for amending the opinion adopted on 15 July 2009. The proposal was rejected by the majority of CVMP members. Given that no absolute majority was attained, the opinion of 15 July 2009 stands. 

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II. 

The opinion was converted into a Decision by the European Commission on 22 July 2010.

Name Language First published Last updated
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information BG = bălgarski 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information ES = español 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information CS = čeština 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information DA = dansk 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information DE = Deutsch 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information ET = eesti keel 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information EL = elliniká 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information EN = English 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information FR = français 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information IT = italiano 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information LV = latviešu valoda 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information LT = lietuvių kalba 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information HU = magyar 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information MT = Malti 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information NL = Nederlands 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information PL = polski 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information PT = português 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information RO = română 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information SK = slovenčina 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information SL = slovenščina 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information FI = suomi 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information SV = svenska 14/12/2010  

Key facts

Approved nameTildren
International non-proprietary name (INN) or common name

tiludronic acid

Associated names
Class
Reference numberEMA/193771/2010
TypeArticle 33
StatusEuropean Commission final decision
Opinion date22/07/2010
EC decision date22/07/2013

All documents

Name Language First published Last updated
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information BG = bălgarski 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information ES = español 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information CS = čeština 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information DA = dansk 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information DE = Deutsch 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information ET = eesti keel 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information EL = elliniká 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information EN = English 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information FR = français 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information IT = italiano 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information LV = latviešu valoda 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information LT = lietuvių kalba 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information HU = magyar 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information MT = Malti 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information NL = Nederlands 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information PL = polski 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information PT = português 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information RO = română 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information SK = slovenčina 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information SL = slovenščina 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information FI = suomi 14/12/2010  
Opinion following an Article 33(4) referral for Tildren 500 mg, lyophilisate for solution for infusion: Background information SV = svenska 14/12/2010  
Tildren - Article 33 referral - Annexes I, II BG = bălgarski 14/12/2010  
Tildren - Article 33 referral - Annexes I, II ES = español 14/12/2010  
Tildren - Article 33 referral - Annexes I, II CS = čeština 14/12/2010  
Tildren - Article 33 referral - Annexes I, II DA = dansk 14/12/2010  
Tildren - Article 33 referral - Annexes I, II DE = Deutsch 14/12/2010  
Tildren - Article 33 referral - Annexes I, II ET = eesti keel 14/12/2010  
Tildren - Article 33 referral - Annexes I, II EL = elliniká 14/12/2010  
Tildren - Article 33 referral - Annexes I, II EN = English 14/12/2010  
Tildren - Article 33 referral - Annexes I, II FR = français 14/12/2010  
Tildren - Article 33 referral - Annexes I, II IT = italiano 14/12/2010  
Tildren - Article 33 referral - Annexes I, II LV = latviešu valoda 14/12/2010  
Tildren - Article 33 referral - Annexes I, II LT = lietuvių kalba 14/12/2010  
Tildren - Article 33 referral - Annexes I, II HU = magyar 14/12/2010  
Tildren - Article 33 referral - Annexes I, II MT = Malti 14/12/2010  
Tildren - Article 33 referral - Annexes I, II NL = Nederlands 14/12/2010  
Tildren - Article 33 referral - Annexes I, II PL = polski 14/12/2010  
Tildren - Article 33 referral - Annexes I, II PT = português 14/12/2010  
Tildren - Article 33 referral - Annexes I, II RO = română 14/12/2010  
Tildren - Article 33 referral - Annexes I, II SK = slovenčina 14/12/2010  
Tildren - Article 33 referral - Annexes I, II SL = slovenščina 14/12/2010  
Tildren - Article 33 referral - Annexes I, II FI = suomi 14/12/2010  
Tildren - Article 33 referral - Annexes I, II SV = svenska 14/12/2010  

Document description

  • Opinion - contains the opinion of the Committee for Medicinal Products for Veterinary use (CVMP) on 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 may not always be available:

  • Changes to the summary of product characteristics, labeling or package leaflet ('annex III') - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (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