COMUNICATO - Autorizzazione all''importazione parallela del medicinale «Buscapina 10 mg comprimidos recubiertos»
Estratto determinazione AIP/UPC n. 178 del 20 novembre 2008
E' autorizzata l'importazione parallela del medicinale BUSCAPINA 10 mg comprimidos recubiertos dalla Spagna con numero di autorizzazione 62.285 CN 656750-0 alle condizioni e con le specificazioni di seguito indicate:
Importatore: Farma 1000 S.r.l. con sede legale e domicilio fiscale in via Camperio n. 9 - 20123 Milano.
Denominazione e confezione: Buscapina «10 mg compresse rivestite» 30 compresse rivestite.
Codice IP: 038788016 (in base 10), 14ZQXJ (in base 32).
Forma farmaceutica: compresse rivestite.
Composizione: una compressa rivestita contiene:
principio attivo: N-butilbromuro di joscina 10 mg;
eccipienti: nucleo: calcio idrogenofosfato, amido di mais, amido solubile, silice colloidale anidra, acido tartarico, acido palmito-stearico; rivestimento: povidone, saccarosio, talco, gomma arabica, titanio diossido (E 171), macrogol 6000, cera carnauba, cera bianca.
Indicazioni terapeutiche: trattamento sintomatico delle manifestazioni spastico-dolorose del tratto gastroenterico e genito-urinario.
Confezionamento secondario:
e' autorizzato riconfezionamento secondario presso l'officina Fiege Logistics Italia...
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