COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Benzac» (21A01875)
Estratto determina IP n. 260 del 19 marzo 2021
Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale BENZAC 5% gel 1 tubo da 40 g dal Belgio con numero di autorizzazione BE125903, intestato alla societa' Galderma Benelux B.V. Gravinnen Van Nassauboulevard 91, 4811 BN Breda - Paesi Bassi e prodotto da Laboratoires Galderma - 74540 Alby-Sur-Cheran - Francia, 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, 9 - 20123 Milano.
Confezione: BENZAC «5% gel» tubo 40 g.
Codice A.I.C. n. 049292016 (in base 10) 1H08RJ(in base 32).
Forma farmaceutica: gel composizione: 100 g di gel contengono:
principio attivo: 5 g di perossido di benzoile
eccipienti: carbomer 940, copolimero metacrilico, glicerina, disodio edetato, diottil sodio sulfosuccinato, silice colloidale, propilen glicole, poloxamer 182, idrossido di sodio, acqua demineralizzata.
Benzac 5% gel contiene propilene glicole Benzac 5% gel contiene il 4% di propilene glicole, corrispondente a 40 mg per ogni grammo di gel.
Officine di confezionamento secondario:
S.C.F. S.r.l. via F. Barbarossa, 7 - 26824 Cavenago d'Adda - LO
XPO Supply Chain Pharma Italy S.p.a. via Amendola, 1 - 20049 Caleppio di Settala (MI)
De Salute S.r.l. via Biasini, 26 - 26015 Soresina (CR).
Classificazione ai fini della rimborsabilita'
Confezione: BENZAC «5% gel» tubo 40 g - codice A.I.C. n. 049292016.
Classe di rimborsabilita': C-bis.
Classificazione ai fini della fornitura
Confezione: BENZAC «5% gel» tubo 40 g - codice A.I.C. n. 049292016.
OTC - medicinali non soggetti a prescrizione medica da banco.
Stampati
Le confezioni del medicinale importato devono essere poste in commercio con etichette e foglio illustrativo conformi al testo in italiano allegato e...
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