Décision portant prolongation de la soumission de l'exportation du médicament Bleomycine Sanofi 15000 IU destiné au marché belge à une autorisation préalable, de 27 mars 2024
Article M.
Décision portant prolongation de la soumission de l'exportation du médicament Bleomycine Sanofi 15000 IU destiné au marché belge à une autorisation préalable
Le Ministre de la Santé publique,
Vu la loi du 25 mars 1964 sur les médicaments à usage humain, l'article 12septies, alinéa 2 ;
Vu l'arrêté royal du 19 janvier 2023 portant exécution de l'article 12septies, alinéa 2, de la loi du 25 mars 1964 sur les médicaments, l'article 4, § 1er et § 2, alinéa 3;
Vu la décision du 16 février 2023 soumettant l'exportation du médicament Bleomycine Sanofi 15000 IU destiné au marché belge à une autorisation préalable;
Considérant que l'interruption de la mise sur le marché au sens de l'article 2, 30), de l'arrêté royal du 14 décembre 2006 relatif aux médicaments à usage humain et vétérinaire, du médicament Bleomycine Sanofi 15000 IU a été communiquée à l'AFMPS ;
Considérant que l'indisponibilité du médicament Bleomycine Sanofi 15000 IU se poursuivrait jusqu'au 2 mars 2025 ;
Considérant que le médicament Bleomycin Sanofi 15000 IU est utilisé pour le traitement des carcinomes spinocellulaires de la bouche, du nasopharynx et des sinus paranasaux, du larynx, de l'oesophage, des organes génitaux externes, du col de l'utérus et de la peau, de la maladie de Hodgkin et des lymphomes non hodgkiniens et des carcinomes testiculaires ;
Que l'administration du médicament doit se faire une ou...
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