20 AVRIL 2004. - Arrêté ministériel portant suspension de la délivrance des médicaments contenant du tolcapone
Le Ministre des Affaires Sociales et de la Santé publique,
Vu la loi du 25 mars 1964 sur les médicaments, notamment l'article 8, modifié par la loi du 20 octobre 1998;
Vu la décision de la Commission du 14 janvier 2004 suspendant l'autorisation de mise sur le marché du médicament à usage humain « Tasmar-Tolcapone »;
Vu l'arrêté ministériel du 10 avril 2002 portant suspension de la délivrance des médicaments contenant du tolcapone;
Vu l'avis de la Commission des médicaments du 12 décembre 2003;
Vu l'avis n° 36.774/3 du Conseil d'Etat, donné le 22 mars 2004, en application de l'article 84, § 1er, 2° des lois coordonnées sur le Conseil d'Etat;
Vu l'urgence, motivée par les circonstances que :
-l'arrêté ministériel du 10 avril 2002 portant suspension de la délivrance des médicaments contenant du tolcapone vient à échéance le 18 avril 2004;
- il existe des raisons de considérer que les effets du tolcapone pourraient être nocifs, notamment en causant des dysfonctionnements sérieux du foie;
- à ce titre la Commission européenne a prolongé la suspension de...
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