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 Drug Agency;
Having regard to the marketing authorization decision (AMM) granted on 23 December 1980, to the veterinary drug known as COLLIER ANTIPARASITAIRE CHIEN AU DIMPYLATE BIOVE, necklace, LABORATOIRES BIOVE, 3, rue de Lorraine, 62510 Arques;
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 BIOVE LABORATOIRES on September 14, 2009, 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;
Given the fact that the LABORATOIRES BIOVE was notified on 3 February 2012;
Considering the responses of the BIOVE LABORATOIRES dated 14 February 2012, 8 March 2012 and 27 March 2012, waiving to provide 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 CHIEN IN DIMPYLATE BIOVE contains the active substance dimpylate and claims an action duration of 120 days;
Considering that the ANTIPARASITARY COLLIER medication CHIEN TO DIMPYLATE BIOVE 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 COLLIER ANTIPARASITAIRE CHIEN TO DIMPYLATE BIOVE is considered unfavourable,
The Director of the National Veterinary Drugs Agency decides:
The authorization to place on the market referred to in Article L. 5141-5 and granted on 23 December 1980 to the veterinary drug COLLIER ANTIPARASITAIRE CHIEN AU DIMPYLATE BIOVE, necklace, LABORATOIRES BIOVE, 3, rue de Lorraine, 62510 Arques, is deleted as from the notification of this decision.
