COMUNICATO - Autorizzazione all''importazione parallela del medicinale «Noctamid 2,5 mg/ml gotas orales in solucion 20 ml»
Estratto determinazione AIP/UPC n. 175 del 20 novembre 2008
E' autorizzata l'importazione parallela del medicinale NOCTAMID 2,5 mg/ml gotas orales in solucion 20 ml dalla Spagna con numero di autorizzazione 63332 CN 902155.9, 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: Minias «2,5 mg/ml gocce orali, soluzione» flacone 20 ml.
Codice IP: 038793016 (in base 10), 14ZVTS (in base 32).
Forma farmaceutica: gocce orali, soluzione.
Composizione: 100 ml di soluzione contengono:
principio attivo: Lormetazepam 0,250 g;
eccipienti: saccarina sodica, aroma di arancio, essenza di limone, aroma di caramello, glicerolo, alcool etilico 95%, glicole propilenico.
Indicazioni terapeutiche: trattamento a breve termine dell'insonnia caratterizzata da disturbi dell'addormentamento e della continuita' del sonno, specialmente su base ansiosa. Il Minias, cosi' come tutti i prodotti appartenenti alla stessa classe terapeutica, e' indicato soltanto quando il disturbo e' grave e provoca notevole disagio al paziente.
Confezionamento secondario:
e' autorizzato riconfezionamento...
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