Key Benefits:
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 17 June 1987, to the veterinary drug known as COLLIER ANTIPARASITAIRE CHIEN AU DIMPYLATE FRISKIES, necklace, laboratory SOPARLIC, 13th-Rue LID, 06517 Carros Cedex ;
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;
Considering the letter sent to the SOPARLIC laboratory on September 14, 2009 indicating that there was a risk to the user and requesting studies to demonstrate the safety of the drug to 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;
Considering the SOPARLIC laboratory responses of 24 February 2012 and 6 March 2012 proposing no 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 drug COLLIER ANTIPARASITAIRE CHIEN TO DIMPYLATE FRISKIES contains the active substance dimpylate and claims a duration of action of 120 days;
Considering that the COLLIER ANTIPARASITAIRE CHIEN IN FRISKIES DIMPYLATE 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 17 June 1987 to the veterinary drug COLLIER ANTIPARASITAIRE CHIEN AU DIMPYLATE FRISKIES, necklace, from the SOPARLIC laboratory, 13th-Rue LID, 06517 Carros Cedex, is deleted from the notification of this decision.
