COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Fenistil» (24A01786)
Estratto determina IP n. 204 del 28 marzo 2024 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale FENISTIL GEL 30 G 0,1% 1 tubo da 30 g dalla Grecia con numero di autorizzazione 42245/24-9-2008, intestato alla societa' GSK CH Hellas Single Member S.A. Leof. Kifisias 274, 152 32 Halandri, Grecia e prodotto da Haleon Germany GmbH Barthstrasse 4, Bavaria, 80339 Monaco Germania e da Glaxosmithkline Consumer Healthcare GmbH &Co. KG, Barthstrasse 4, 80339 Monaco Germania con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: Farma 1000 S.r.l. con sede legale in via Camperio Manfredo n. 9 - 20123 Milano. Confezione: FENISTIL «0,1% gel» tubo gel 30 g - codice A.I.C. n. 039346022 (in base 10) 151RV6 (in base 32). Forma farmaceutica: gel. Composizione: 100 g di gel contengono: principio attivo: 100 mg di dimetindene maleato eccipienti: benzalconio cloruro, sodio edetato, carbopol 974 P, sodio idrossido 30%, propilenglicole, acqua depurata. Officine di confezionamento secondario: De Salute S.r.l., via Biasini n. 26 - 26015 Soresina (CR) S.C.F. S.r.l., via F. Barbarossa n. 7 - 26824 Cavenago d'Adda(LO) Pharma Partners S.r.l., via E. Strobino n. 55/57 - 59100 Prato(PO) Falorni S.r.l., via dei Frilli n. 25 - 50019 Sesto Fiorentino(FI) Chiapparoli Logistica S.p.a., via Morolese s.n.c. - 03012 Anagni (FR) GXO Logistics Pharma Italy S.p.a., via Amendola n. 1 - 20049 Caleppio di Settala (MI). Classificazione ai fini della rimborsabilita' Confezione: FENISTIL «0,1% gel» tubo gel 30 g - codice A.I.C. n. 039346022. Classe di rimborsabilita': C-bis. Classificazione ai fini della fornitura Confezione: FENISTIL «0,1% gel» tubo...
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