Décision soumettant l'exportation du médicament Actilyse destiné au marché belge à une autorisation préalable, de 20 février 2023
Article M.
DECIDE de soumettre l'exportation des médicaments Actilyse 50 mg/50 ml sol. inj./perf. (pdr. + solv.) i.v. et Actilyse 20 mg/20 ml sol. inj./perf. (pdr. + solv.) i.v.destinés au marché belge à une autorisation préalable jusqu'au 31 décembre 2023 inclus.Cette décision entre en vigueur le jour de sa publication dans le Moniteur belge.
Signatures
Bruxelles, le 16 février 2023.
F. VANDENBROUCKE
Préambule
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 18 janvier 2023 portant exécution de l'article 12septies, alinéa 2, de la loi du 25 mars 1964 sur les médicaments, l'article 4, § 1er, § 2, alinéa 1er et § 3, alinéa 1er ;
Considérant que l'indisponibilité au sens de l'article 2, 29), de l'arrêté royal du 14 décembre 2006 relatif aux médicaments à usage humain et vétérinaire, du médicament Actilyse a été communiquée à l'AFMPS ;
Considérant que l'indisponibilité du médicament Actilyse se poursuivrait jusqu'au 31 décembre 2023;
Considérant que le médicament Actilyse est utilisé pour le traitement de l'infarctus aigu du myocarde, le traitement de l'accident vasculaire cérébral ischémique aigu ou le...
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