COMUNICATO - Rinnovo dell''autorizzazione all''immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale «Zolpidem Hexal» con modifica degli stampati. (12A10005)
Estratto determinazione V & A/1102 del 20/08/2012
Specialita' medicinale: ZOLPIDEM HEXAL
Confezioni:
A.I.C. n. 038162018/M - "10 mg compresse rivestite con film" 10 compresse in blister pvc/pe/pvdc/al
A.I.C. n. 038162020/M - "10 mg compresse rivestite con film" 14 compresse in blister pvc/pe/pvdc/al
A.I.C. n. 038162032/M - "10 mg compresse rivestite con film" 15 compresse in blister pvc/pe/pvdc/al
A.I.C. n. 038162044/M - "10 mg compresse rivestite con film" 20 compresse in blister pvc/pe/pvdc/al
A.I.C. n. 038162057/M - "10 mg compresse rivestite con film" 28 compresse in blister pvc/pe/pvdc/al
A.I.C. n. 038162069/M - "10 mg compresse rivestite con film" 30 compresse in blister pvc/pe/pvdc/al
A.I.C. n. 038162071/M - "10 mg compresse rivestite con film" 100 compresse in blister pvc/pe/pvdc/al
A.I.C. n. 038162083/M - "10 mg compresse rivestite con film" 30 compresse in contenitore hdpe
A.I.C. n. 038162095/M - "10 mg compresse rivestite con film" 100 compresse in contenitore hdpe
A.I.C. n. 038162107/M - "10 mg compresse rivestite con film" 500 compresse in contenitore hdpe
A.I.C. n. 038162119/M - "10 mg compresse rivestite con film" 50x1 compresse in blister pvc/pe/pvdc/al (confezione ospedaliera)
Titolare AIC: Hexal S.p.a.
Numero Procedura Mutuo Riconoscimento: NL/H/0950/001/R/001 - NL/H/950/01/IB/08
Tipo di Modifica: Rinnovo Autorizzazione - Modifica Stampati
Modifica apportata: e' autorizzata la modifica del Riassunto delle Caratteristiche del Prodotto, dei corrispondenti paragrafi del Foglio Illustrativo e delle Etichette a seguito della procedura di rinnovo europeo. E' autorizzato altresi', l'aggiornamento del Riassunto delle Caratteristiche del Prodotto e del Foglio Illustrativo a seguito di un post approval committment durante la procedura di PSUR per Zolpidem. Gli stampati corretti ed approvati sono allegati alla determinazione.
In ottemperanza all'art. 80 commi 1 e 3 del decreto legislativo 24...
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