Décisions du 9 octobre 2000 interdisant des publicités pour des médicaments mentionnées à l'article L. 5122-1, premier alinéa, du code de la santé publique, destinées aux personnes habilitées à prescrire ou à délivrer ces médicaments ou à les utiliser dans l'exercice de leur art
Jurisdiction | France |
Publication au Gazette officiel | JORF n°253 du 31 octobre 2000 |
Record Number | JORFTEXT000000585275 |
Date de publication | 31 octobre 2000 |
Court | MINISTERE DE L'EMPLOI ET DE LA SOLIDARITE |
Enactment Date | 09 octobre 2000 |
Par décision du directeur général de l'Agence française de sécurité sanitaire des produits de santé en date du 9 octobre 2000, considérant que le laboratoire Thérabel Lucien Pharma, 15, rue de l'Hôtel-de-Ville, 92522 Neuilly-sur-Seine Cedex, a diffusé une publicité relative à la spécialité Nexen - aide de visite ; considérant que, pages 1, 2, 3, 10 et 11, il est allégué « AINS Quels choix pour soulager ? », « AINS vos choix », « Nexen face aux autres AINS », « Votre alternative Nexen » et sont présentées des études comparant Nexen aux autres AINS sans que soit précisée l'indication validée par l'autorisation de mise sur le marché de Nexen, ce qui n'est pas acceptable, car susceptible d'engendrer une confusion sur-le-champ de l'indication de Nexen dans l'esprit du prescripteur, l'autorisation de mise sur le marché étant plus restrictive que celle des autres AINS, limitant son usage au « traitement symptomatique des arthroses douloureuses et invalidantes » ; considérant que, pages 4 et 5, l'allégation « En respectant les PG-physiologiques : hémostase » n'est pas conforme à l'autorisation de mise sur le marché de la spécialité Nexen qui précise que le nimésulide possède une « activité inhibitrice de courte durée des fonctions plaquettaires » ; considérant que, pages 8 et 9, l'allégation « Face à un patient fragile, Nexen...
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