Modificazione dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, della specialita' medicinale .
Estratto provvedimento UPC/II/2372 del 5 luglio 2006
Specialita' medicinale: ANZEMET.
Confezioni:
033108010/M - IV 10 fiale 20 mg/ml 0,625 ml;
033108022/M - IV 1 fiala 20 mg/ml 5 ml;
033108034/M - 3 compresse film rivestite 50 mg;
033108046/M - 3 compresse film rivestite 200 mg.
Titolare A.I.C.: Aventis Pharma S.p.a.
Numero procedura mutuo riconoscimento: UK/H/0150/001-003/II/023.
Tipo di modifica: modifica urgente di stampati.
Modifica apportata: a seguito di una seria rivalutazione del profilo di sicurezza il prodotto viene controindicato nei bambini e negli adolescenti a causa di un grave rischio cardiovascolare con conseguenti modifiche al riassunto delle caratteristiche del prodotto nelle sezioni 4.2, 4.3, 4.4, 4.6, 5.2 e 7.
Il titolare dell'autorizzazione all'immissione in commercio della specialita' medicinale in questione deve apportare le necessarie modifiche al riassunto delle...
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