Doxyfar 50% - referral

Current status

European Commission final decision

Overview

Doxycycline is a semi-synthetic tetracycline antibiotic. Tetracyclines have broad spectrum activity inhibiting Gram-positive and Gram-negative bacteria, mycoplasmas, chlamydiae, rickettsias and some protozoa. Doxyfar 50 % and associated names is a powder for use in drinking water containing the active substance doxycycline hyclate 500 mg/g. The product is indicated for the treatment of certain infections of the respiratory tract in pigs and chickens.

Due to divergent national decisions taken by Member States regarding the target species, indications, amounts to be administered and withdrawal periods concerning the authorisation of Doxyfar 50% and associated names, on 18 June 2010 the United Kingdom referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences amongst the nationally authorised summary of product characteristics across the European Union.

The referral procedure started on 14 July 2010. The Committee appointed Mrs Ruth Kearsley as rapporteur and Dr Jiří Bureš as co-rapporteur. Further to the resignation of Mrs Ruth Kearsley as CVMP member, Ms Helen Jukes was appointed to replace her and took over the rapporteurship. Written explanations were provided by the applicant/marketing authorisation holder on 15 October 2010 and 8 March 2011.

Based on the rapporteurs' assessment of the currently available data, the CVMP considered that the benefit/risk profile for Doxyfar 50% and associated names remains positive subject to variation of the marketing authorisations in accordance with the summary of product characteristics, and therefore adopted a positive opinion on 4 May 2011.

The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics in Annex III.

The final opinion was converted into a Decision by the European Commission on 13 July 2011.

Opinion following an Article 34 referral for Doxyfar 50% and associated names: Background information

AdoptedReference Number: EMA/512470/2011

Key facts

About this medicine

• Approved name:
  Doxyfar 50%
• International non-proprietary name (INN) or common name:
  doxycycline hyclate
• Associated names:
  • Soludox 500 mg/g
  • Soludox Vet
  • Soludox 433 mg/g
  • Doxy Ort 50%

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMA/512470/2011
• Type:
  Article 34

  Divergent decision referral: initiated in order to obtain harmonisation within the EU of the conditions of authorisation for products already authorised by Member States.

Key dates and outcomes

• Opinion date:
  04/05/2011
• EC decision date:
  13/07/2011

All documents

Doxyfar 50% - Article 34 referral - Annex I, II, III

Opinion following an Article 34 referral for Doxyfar 50% and associated names: Background information

AdoptedReference Number: EMA/512470/2011

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
• 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. veterinary healthcare professionals, farmers, academia) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of CVMP
• Divergent positions – divergent positions of the CVMP members (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)