Modificazione dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, della specialita' medicinale .
Estratto provvedimento UPC/II/2305 del 10 aprile 2006
Specialita' medicinale: OMBEX.
Confezioni:
A.I.C. n. 036479018/M - ´1% cremaª tubo in alluminio da 15 g;
A.I.C. n. 036479020/M - ´1% cremaª tubo in alluminio da 30 g;
A.I.C. n. 036479032/M - ´1% cremaª tubo in alluminio da 60 g;
A.I.C. n. 036479044/M - ´1% cremaª tubo in alluminio da 100 g.
Titolare A.I.C.: LPB Istituto Farmaceutico S.r.l.
N. procedura mutuo riconoscimento: DK/H/0340/001/II/013.
Tipo di modifica: modifica stampati.
Modifica apportata: modifica del riassunto delle caratteristiche del prodotto nelle sezioni 4.8 e 5.1.
Il Titolare dell'autorizzazione all'immissione in commercio della specialita' medicinale in questione deve apportare le necessarie modifiche al riassunto delle caratteristiche del prodotto dalla data di entrata in vigore del presente...
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