Soludox

Table of contents

Current status
European Commission final decision

Overview

Soludox 500-mg/g powder for use in drinking water for pigs and chickens contains doxycycline hyclate as its active ingredient. It is indicated in chickens to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by Ornithobacterium rhinotracheale (ORT). There are two authorised dosages: 10 mg/kg bw for four consecutive days, for which the withdrawal period is 3 days, and 20 mg/kg bw for four consecutive days, for which the withdrawal period is 12 days.

The marketing-authorisation holder, Eurovet Animal Health BV submitted an application for a type-II variation to shorten the withdrawal period in chickens to six days for Soludox 500-mg/g powder for use in drinking water for pigs and chickens and associated names, which was subject to a worksharing procedure by the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) according to Article 20 of Commission Regulation (EC) No 1234/2008. The reference Member State (RMS) is the United Kingdom and 12 concerned Member States (CMS) are involved: Austria, the Czech Republic, Estonia, Finland, France, Germany, Greece, Italy, Latvia, the Netherlands, Slovakia and Spain.

The worksharing procedure (UK/V/xxxx/WS/006) involving Soludox-500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/WS/002) and Soludox 500-mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/WS/002) started on 6 January 2012. Potential serious risks were identified during the decentralised procedure by the Netherlands regarding the appropriate withdrawal period for chicken meat and offal.

On day 90, these issues remained unsolved and therefore a referral under Article 13(1) of Commission Regulation (EC) No. 1234/2008 to the CMDv was started on 20 August 2012. Day 60 of the CMDv procedure was on 18 October 2012, and since the Member States concerned failed to reach an agreement, the procedure was referred to the Committee for Medicinal Products for Veterinary Use (CVMP).

On 30 October 2012, the reference Member State, the United Kingdom, notified the European Medicines Agency that the CMDv had failed to reach an agreement and referred the matter to the CVMP pursuant to Article 13(2) of Commission Regulation (EC) No. 1234/2008.

The referral procedure started on 7 November 2012. The Committee appointed Mr J. Schefferlie as rapporteur and Ms H. Jukes as co-rapporteur. Written explanations were provided by the marketing-authorisation holder on 8 January 2013. Oral explanations were given on 5 March 2013.

Based on the evaluation of the available data the CVMP adopted, on 7 March 2013, an opinion recommending the granting of the variation of the marketing authorisations for Soludox 500-mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/WS/002) and Soludox 500-mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/WS/002). The CVMP concluded that a withdrawal period of nine days is appropriate for chickens for the dose of 20 mg/kg bw for four consecutive days.

On 22 March 2013, Eurovet Animal Health BV notified the Agency of its intention to request a re-examination of the CVMP opinion of 7 March 2013.

During its meeting of 9-11 April 2013 the CVMP appointed Prof. C. Friis as the rapporteur and Dr M. Holzhauser-Alberti as the co-rapporteur for the re-examination procedure.

The detailed grounds for the re-examination request were submitted by Eurovet Animal Health BV on 26 April 2013. The re-examination procedure started on 27 April 2013.

On 12 June 2013, the CVMP adopted a final opinion confirming the recommendation included in its opinion of 7 March 2013, that the variation of the marketing authorisations for Soludox-500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/WS/002) and Soludox 500-mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/WS/002) can be granted and a withdrawal period of nine days is appropriate for chickens for the dose of 20 mg/kg bw for four consecutive days.

The list of product names concerned is given in annex I. The scientific conclusions are provided in annex II, together with the summary of product characteristics and package leaflet in annex III.

The opinion was converted into a decision by the European Commission on 12 August 2013.

Key facts

Approved name
Soludox
International non-proprietary name (INN) or common name
doxycycline hyclate
Current status
European Commission final decision
Reference number
EMEA/V/A/090
Type
Article 13

This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II).
Opinion date
12/06/2013
EC decision date
12/08/2013

All documents

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)

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