Doxyfar 50%

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.

Key facts

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%
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.

Status
European Commission final decision
Opinion date
04/05/2011
EC decision date
13/07/2011

All documents

Document description

  • Opinion - contains the CVMP 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 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

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