COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Lendormin» (18A05497)
Estratto determina IP n. 546 del 17 luglio 2018 E' autorizzata l'importazione parallela del medicinale LENDORMIN 0,25 mg tabletten 20 tabletten dalla Germania con numero di autorizzazione 5612.00.00, intestato alla societa' Boehringer Ingelheim PHARMA GmbH &
Co. KG e prodotto da Delpharm Reims S.A.S. (BS1) con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: GMM Farma S.R.L. con sede legale in Via Lambretta, 2 - 20090 Segrate (MI). Confezione: «Lendormin» «0,25 mg compresse» 30 compresse;
codice A.I.C.: 045101021 (in base 10) 1C0CYX (in base 32). Forma farmaceutica: compresse. Composizione: ogni compressa contiene: principi attivi: Brotizolam 0,25 mg;
eccipienti: lattosio monoidrato, amido di mais, amido sodio glicolato, cellulosa microcristallina, magnesio stearato. Indicazioni terapeutiche: trattamento a breve termine dell'insonnia. Le benzodiazepine sono indicate solamente quando l'insonnia e' grave, disabilitante e sottopone il soggetto a grave disagio. Officine di confezionamento secondario: S.C.F. S.r.l. Via F. Barbarossa, 7 - 26824 Cavenago d'Adda (LO);
De Salute S.R.L. Via Biasini, 26 - 26015 Soresina Cremona;
XPO Supply Chain Pharma Italy S.P.A. Via Amendola, 1 - Settala loc. Caleppio - 20090 Milano. Classificazione ai fini della rimborsabilita' Confezione: «Lendormin» «0,25 mg compresse» 30 compresse;
codice A.I.C.: 045101021;
classe di rimborsabilita': «C(nn)». La confezione sopradescritta...
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