17 SEPTEMBRE 2005. - Arrêté royal portant interdiction de la délivrance de certains médicaments contenant de l'éphédrine
ALBERT II, Roi des Belges,
A tous, présents et à venir, Salut.
Vu la loi du 25 mars 1964 sur les médicaments, notamment l'article 7, modifié par la loi du 20 octobre 1998;
Vu l'arrêté royal du 3 juillet 1969 relatif à l'enregistrement des médicaments, notamment l'article 23;
Vu les avis de la Commission des médicaments, donnés le 8 novembre 2002, 13 décembre 2002, 19 mars 2004, 10 septembre 2004 et 10 décembre 2004;
Considérant la nécessité d'interdire la délivrance de certains médicaments contenant de l'éphédrine motivée par les circonstances que :
- les médicaments contenant de l'éphédrine peuvent être nocifs pour la santé du patient. Il est donc nécessaire non seulement de retirer les médicaments du marché mais également d'interdire les préparations officinales ou magistrales contenant cette substance;
- des effets indésirables graves au niveau cardio-vasculaire tels que : infarctus, hypertension artérielle, cardiomyopathie, accident vasculaire cérébral ou troubles du rythme cardiaque et aussi des convulsions, des psychoses et des décès ont été observés au niveau mondial chez des patients suite à la prise de médicaments contenant une forte dose d'éphédrine;
- les effets de la prise d'éphédrine pourraient être nocifs, en particulier lors de leur utilisation comme anorexigène;
Considérant qu'il est nécessaire d'exempter de la mesure d'interdiction de la délivrance les médicaments contenant de l'éphédrine à usage parentéral du fait que ces médicaments se révèlent efficaces;
Considérant le fait que dans ce cas, il n'y a pas de risque d'usage dévié qui pourrait être nocif, notamment en raison de leur administration par un professionnel de la santé;
Considérant qu'une exemption doit également être prise pour les médicaments...
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