COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Lendormin» (24A01783)
Estratto determina IP n. 201 del 28 marzo 2024 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale LENDORMIN 0,250 mg tabletten 20 tabletten dai Paesi Bassi con numero di autorizzazione RVG 10015, intestato alla societa' Boehringer Ingelheim B.V. Basisweg 10 1043 AP Amsterdam Paesi Bassi e prodotto da Delpharm Reims 10 Rue Colonel Charbonneaux 51100 Reims Francia, con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Farmed S.r.l. con sede legale in via Cavallerizza a Chiaia n. 8 - 80121 Napoli (NA). Confezione: LENDORMIN «0,25 mg compresse» 30 compresse in blister PVC/PVDC/AL - codice A.I.C.: 048580031 (in base 10) 1GBKFZ (in base 32). Forma farmaceutica: compressa. Composizione: una compressa contiene: principio attivo: brotizolam 0,25 mg eccipienti: lattosio monoidrato, amido di mais, sodio amido glicolato, cellulosa microcristallina (E460), magnesio stearato(E470B). Modificare le condizioni di conservazione riportate al paragrafo 5 «Come conservare Lendormin» del foglio illustrativo e sul confezionamento secondario come di seguito indicato: conservare a temperatura inferiore a 25°C, nella confezione originale. Officine di confezionamento secondario: De Salute S.r.l. - via Biasini n. 26 - 26015 Soresina (CR) GXO Logistics Pharma Italy S.p.a. - via Amendola n. 1 - 20049 Caleppio di Settala (MI) S.C.F. S.r.l. - via F. Barbarossa n. 7 - 26824 Cavenago d'Adda(LO). Classificazione ai fini della rimborsabilita' Confezione: LENDORMIN «0,25 mg compresse» 30 compresse in blister PVC/PVDC/AL - codice A.I.C.: 048580031. Classe di rimborsabilita': C. Classificazione ai fini della fornitura Confezione...
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