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Notice Of Removal Of Authorisation For Placing On The Market Of Veterinary Drug

Original Language Title: Avis relatif à la suppression d'une autorisation de mise sur le marché de médicament vétérinaire

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JORF n°0136 of 13 June 2012 page 9984
text No. 130



Notice regarding the removal of a veterinary drug marketing authorization

NOR: AFSU1200126S ELI: Not available



Decision of 5 April 2012 of the Director
National Veterinary Drugs Agency


In view of the fifth part, Book I of the Public Health Code, including articles L. 5141-6, R. 5141-42 and R. 5141-44;
In light of Decision No. 2010-09-056 of 9 September 2010 on delegation of authority from the Director General of the National Health Safety Agency for Food, Environment and Labour to the Director of the National Veterinary Drug Agency;
Considering the marketing authorization decision (AMM) granted on November 13, 2006, to the veterinary drug called ANTIPARASITARY COLLIER REFLECHISSING TO DIMPYLATE FOR CHAT VITALVETO, necklace, SOPARLIC laboratory, 13th Lid Street, 06517 Cedex Carros;
See?Order No. 2001-378 of 2 May 2001 which has transposed the guidelines on veterinary drugs with regard to the detailed delivery of certain veterinary pest control drugs;
Considering the reassessment of the safety of the user conducted by the VAN on active substances contained in external pest control veterinary drugs for pets;
In view of the letter sent to the SOPARLIC laboratory on September 14, 2009, indicating that there was a risk to the user, and asking for studies to demonstrate the safety of the drug for the user;
Based on the results of the study transmitted on December 23, 2010 to the ANAMV in order to assess the chronic exposure of the child by skin (test of the cotton glove) and which revealed unfavourable results for dimpylate-based collars of 120 days of action;
Having been notified to the SOPARLIC laboratory on 3 February 2012;
Given the SOPARLIC laboratory responses dated 24 February 2012 and 6 March 2012, not proposing satisfactory measures;
Based on the advice of the National Commission on Veterinary Drugs,Article R. 5141-47 of the Public Health Code of 20 March 2012;
Considering that the ANTIPARASITARY COLLIER drug REFLECHISSING TO DIMPYLATE FOR CHAT VITALVETO contains the active substance dimpylate and claims an action duration of 120 days;
Considering that the ANTIPARASITARY COLLIER drug REFLECHISSING TO DIMPYLATE FOR CHAT VITALVETO presents the characteristics of the pest control collars that have been the subject of the study carried out (test of the cotton glove);
Considering therefore that the risk-benefit ratio of the drug is considered unfavourable,
The Director of the National Veterinary Drugs Agency decides:
The marketing authorization referred to in article L. 5141-5 and granted on 13 November 2006 to the veterinary drug COLLIER ANTIPARASITAIRE REFLECHISSING TO DIMPYLATE FOR CHAT VITALVETO, necklace, SOPARLIC laboratory, 13th Lid Street, 06517 Carros Cedex, is deleted from the notification of this decision.


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