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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 9974
text No. 103



Notice regarding the removal of a veterinary drug marketing authorization

NOR: AFSU1200099S 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 Drugs Agency;
Considering the marketing authorization decision (AMM) granted on 1 February 1982 to the veterinary drug known as COLLIER ANTIPARASITAIRE CHAT AU DIMPYLATE SHS, necklace, from the laboratory AB7 VETERINARY INDUSTRIES, chemin des Monges, Deyme, 31450 Montgiscard ;
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 AB7 VETERINARY INDUSTRIES laboratory on October 28, 2010, indicating that there was a risk to the user and requesting studies to demonstrate the safety of the drug for the user;
Considering the results of the study transmitted on 17 February 2011 to the ANMV, carried out by the PHATOPHY laboratory on behalf of this licensee, in order to evaluate the chronic exposure of the child by skin (coffee glove test) and which revealed inconsistent results for the dimpylate-based collars of 120 days of action;
Having been notified to AB7 VETERINARY INDUSTRIES laboratory on 3 February 2012;
Based on the responses of the AB7 VETERINARY INDUSTRIES laboratory dated 15 February 2012, 28 February 2012 and 9 March 2012 not providing a new complementary study;
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 drug COLLIER ANTIPARASITAIRE CHAT TO DIMPYLATE SHS contains the active substance dimpylate and claims 120 days of action;
Considering that the COLLIER ANTIPARASITAIRE CHAT TO DIMPYLATE SHS presents the characteristics of the pest control collars that have been the subject of the study carried out by the PHATOPHY laboratory;
Considering that the results of this study do not allow for the conclusion of chronic skin risk for the child;
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 1 February 1982 to the veterinary drug COLLIER ANTIPARASITAIRE CHAT AU DIMPYLATE SHS, necklace, from the laboratory AB7 VETERINARY INDUSTRIES, chemin des Monges, Deyme, 31450 Montgiscard, is deleted as from the notification of this decision.


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