Modificazione dell'autorizzazione all'immissione in commercio, secondo procedura di mutuo riconoscimento, di alcune confezioni della specialita' medicinale .
Estratto provvedimento UPC/II/ 2326 del 9 maggio 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.
Numero procedura mutuo riconoscimento: DK/H/0340/001/II/009.
Tipo di modifica: aggiornamento metodica chimico/farmaceutica.
Modifica apportata: aggiunta della forma cristallina ´Bª del principio attivo termodinamicamente piu' stabile.
I lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza indicata in etichetta.
Decorrenza ed efficacia del provvedimento: dalla data della sua pubblicazione nella Gazzetta Ufficiale della Repubblica italiana.
Estratto provvedimento UPC/II/ 2327 del 9 maggio 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...
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