Décision soumettant l'exportation du médicament Actosolv destiné au marché belge à une autorisation préalable, de 20 février 2023
Article M.
DECIDE de soumettre l'exportation dus médicament Actosolv 100000 IU sol. inj./perf. (pdr) i.v./i.artér.et Actosolv 600000 IU sol. inj./perf. (pdr) i.v./i.artér destinés au marché belge à une autorisation préalable jusqu'au 31 mars 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 Actosolv a été communiquée à l'AFMPS ;
Considérant que l'indisponibilité du médicament Actosolv se poursuivrait jusqu'au 31 mars 2023 ;
Considérant que le médicament Actosolv est utilisé pour le traitement d'une embolie pulmonaire étendue et aiguë accompagnée d'un état cardio-vasculaire instable, le traitement d'une thrombose récente de la veine poplitée ou de veines plus proximales, le traitement...
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