Table of contents
Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle is a veterinary medicinal product containing 5 mg moxidectin per ml and 200 mg triclabendazole per millilitre. The product is administered topically on the back of the animal and is indicated for the treatment of mixed nematode and fluke infections in cattle.
The marketing-authorisation holder, Pfizer Animal Health, submitted an application for a type-II variation, in accordance with Article 16 of Commission Regulation (EC) 1234/2008, to add a new indication against lice species (Linognatus vituli, Bovicola bovis and Solenopotes capillatus) for Cydectin TriclaMox 5-mg/ml and 200-mg/ml pour-on solution for cattle. The reference Member State (RMS) was France and 12 concerned Member States (CMSs) were involved: Austria, Belgium, Denmark, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Slovenia, Spain and the United Kingdom.
The type-II-variation procedure (FR/V/0201/002/II/006) started on 16 May 2012. During the variation procedure, a potential serious risk to animal health was identified by Belgium, in particular the issue that the efficacy against the lice species had been insufficiently substantiated.
On day 90, major issues raised by the CMS Belgium remained unsolved. The procedure was thus referred to the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) under Article 13(1) of Commission Regulation (EC) No 1234/2008 on 11 December 2012 by the RMS (France). The CMDv 60-day referral procedure was initiated on 14 January 2013. Day 60 of the CMDv procedure was on 14 March 2013, and since there was no agreement, the procedure was referred to the Committee for Medicinal Products for Veterinary Use (CVMP).
On 3 April 2013, France referred the matter to the CVMP under Article 13(2) of Commission Regulation (EC) No 1234/2008. The CVMP was requested to give its opinion on whether or not the data for the type-II-variation application supported the new indication against lice infestations.
The referral procedure started on 10 April 2013. The Committee appointed Dr B. Urbain as rapporteur and Dr M. Holzhauser-Alberti as corapporteur. Written explanations were provided by the marketing-authorisation holder on 20 May 2013.
Based on the evaluation of the available data, the CVMP adopted, on 16 July 2013, an opinion recommending the granting of the variation to the marketing authorisations for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle. The CVMP concluded that satisfactory efficacy towards Linognatus vituli, Bovicola bovis and Solenopotes capillatus could be expected in the field.
The list of product names concerned is given in annex I. The scientific conclusions are provided in annex II together with the amendments of the relevant sections of the summary of product characteristics, labelling and package leaflet in annex III.
The final opinion was converted into a decision by the European Commission on 25 September 2013.
|International non-proprietary name (INN) or common name||
European Commission final decision
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).
|EC decision date||
Opinion following an Article-13 referral for Cydectin TriclaMox (5 mg/ml and 200 mg/ml) pour-on solution for cattle (PDF/64.05 KB)
First published: 18/10/2013
Last updated: 18/10/2013
Cydectin TriclaMox: Article-13 referral - Annex I, II, III (PDF/89.32 KB)
First published: 18/10/2013
Last updated: 18/10/2013
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)