COMUNICATO - Autorizzazione all''importazione parallela del medicinale «Atarax 25 mg comprimidos recubiertos con pelicula 50 compr.» dalla Spagna. (10A06376)
Estratto determinazione AIP/UPC n. 367 del 18 marzo 2010
E' autorizzata l'importazione parallela del medicinale ATARAX 25 mg comprimidos recubiertos con pelicula 50 compr. dalla Spagna con numero di autorizzazione 26308 Codigo Nacional 757427-9, alle condizioni e con le specificazioni di seguito indicate:
Importatore: BB Farma s.r.l. con sede legale e domicilio fiscale in Viale Europa 160 - 20127 Samarate (Varese).
Confezione: Atarax «25 mg compresse rivestite con film» 20 compresse divisibili.
Codice IP: 038988022 (in base 10) 155U7Q (in base 32).
Forma farmaceutica: compresse divisibili.
Ogni compressa contiene:
Principio attivo: idrossizina dicloridrato 25 mg.
Eccipienti: Nucleo della compressa: lattosio monoidrato, cellulosa microcristallina, magnesio stearato, silice colloidale anidra. Film di rivestimento: Opadry Y-1-7000 [titanio diossido (E171), ipromellosa (E464), macrogol 400].
Indicazioni terapeutiche: trattamento a breve termine degli stati ansiosi. Dermatiti allergiche accompagnate da prurito.
Confezionamento secondario
E' autorizzato riconfezionamento secondario presso l'officina Falorni S.R.L. Via Provinciale Lucchese s.n.c. Loc. Casotti - 51100...
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