Avis relatif à la suppression d'une autorisation de mise sur le marché de médicament vétérinaire
Jurisdiction | France |
Publication au Gazette officiel | JORF n°0136 du 13 juin 2012 |
Date de publication | 13 juin 2012 |
Court | Ministère des affaires sociales et de la santé |
Record Number | JORFTEXT000026018986 |
Décision du 5 avril 2012 du directeur
de l'Agence nationale du médicament vétérinaire
Vu la cinquième partie, livre Ier, du code de la santé publique, et notamment les articles L. 5141-6, R. 5141-42 et R. 5141-44 ;
Vu la décision n° 2010-09-056 du 9 septembre 2010 portant délégation de pouvoirs du directeur général de l'Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail au directeur de l'Agence nationale du médicament vétérinaire ;
Vu la décision d'autorisation de mise sur le marché (AMM) accordée le 6 septembre 2007 au médicament vétérinaire dénommé COLLIER ANTIPARASITAIRE CHAT AU DIMPYLATE VITAKRAFT, collier, des LABORATOIRES BIOVE, 3, rue de Lorraine, 62510 Arques ;
Vu l'ordonnance n° 2001-378 du 2 mai 2001 qui a transposé les directives relatives aux médicaments vétérinaires en ce qui concerne la délivrance au détail de certains médicaments vétérinaires antiparasitaires ;
Vu la réévaluation de la sécurité de l'utilisateur menée par l'ANMV concernant les substances actives contenues dans les médicaments vétérinaires antiparasitaires externes destinés aux animaux de compagnie ;
Vu le courrier adressé aux LABORATOIRES BIOVE le 14 septembre 2009 indiquant qu'il existait un risque pour l'utilisateur et demandant la réalisation d'études afin de démontrer l'innocuité du médicament pour l'utilisateur ;
Vu les résultats de l'étude transmise le 17 février 2011 à l'ANMV, réalisée par le laboratoire PHATOPHY pour le compte de ce titulaire, afin d'évaluer l'exposition chronique de l'enfant par voie cutanée (test du gant de coton) et qui ont révélé des résultats incohérents pour les colliers à base de dimpylate d'une durée d'action de 120 jours ;
Vu la...
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