COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Sildenafil Doc Generici» (17A03817)
Estratto determina PPA n. 519/2017 dell'11 maggio 2017 E' autorizzata la seguente variazione: modifica dei limiti della specifica Water content, al di fuori del range attualmente autorizzato, al rilascio: da NMT 4.0% a NMT 5.0%. Alla shelf-life, resta invariato il limite autorizzato: NMT 6.0%, relativamente alla specialita' medicinale SILDENAFIL DOC GENERICI ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento. Procedura: NL/H/1793/001-003/II/009. Titolare A.I.C.: Doc Generici S.r.l. Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza...
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