COMUNICATO - Autorizzazione all''importazione parallela del medicinale «Zymafluor 1 mg comprime''»
Estratto determinazione AIP/UPC n. 176 del 20 novembre 2008
E' autorizzata l'importazione parallela del medicinale ZYMAFLUOR 1 mg comprime' dalla Francia con numero di autorizzazione 327 424.1 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.
Confezione: Zymafluor «1 mg compresse» 100 compresse.
Codice IP: 038790010 (in base 10), 14ZSVU (in base 32).
Forma farmaceutica: compresse.
Composizione: una compressa contiene:
principio attivo: principio attivo sodio fluoruro 2,211 mg (pari a fluoro-ioni: 1 mg);
eccipienti: sorbitolo; silice colloidale anidra; ossido di ferro giallo (E 172); magnesio stearato.
Indicazioni terapeutiche: sostanza impiegata nella profilassi (prevenzione) della carie dentaria: rende lo smalto dei denti piu' forte, ne favorisce la remineralizzazione e riduce la produzione di acidi da parte della placca batterica.
Confezionamento secondario:
e' autorizzato il riconfezionamento secondario presso le officine: Fiege Logistics Italia S.p.A., via Amendola n. 1 - 20090 Caleppio di...
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