COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Guttalax» (18A07953)
Estratto determina IP n. 780 del 27 novembre 2018 Descrizione del medicinale da importare e attribuzione del numero di identificazione: e' autorizzata l'importazione parallela del medicinale GUTTALAX ORAL DROPS SOLUTION 7,5 mg/ml bottle 15 ml dalla Grecia con numero di autorizzazione 41097/07/14-05-2008, intestato alla societa' Boehringer Ingelheim Hellas S.A. e prodotto da Instituto De Angeli S.r.l. (Firenze Italia), con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: New Pharmashop S.r.l. con sede legale in CIS Di Nola Isola 1, Torre 1, int. 120 80035 Nola NA. Confezione: Guttalax «7,5 mg/ml gocce, soluzione orale» flacone da 15 ml. Codice AIC: 046748012 (in base 10) 1DLNCD (in base 32). Forma farmaceutica: soluzione per uso orale. Composizione: 1 ml (15 gocce) di soluzione contiene: principio attivo: sodio picosolfato 7,50 mg;
eccipienti: metile-para-idrossibenzoato, sorbitolo soluzione al 70%, acqua depurata. Avvertenza da aggiungere al paragrafo 2 del foglio illustrativo relativa all'eccipiente ad effetto noto «Metil-paraidrossibenzoato». Guttalax contiene metil-paraidrossibenzoato. Puo' causare reazioni allergiche (anche ritardate). Officine di confezionamento secondario: S.C.F. S.r.l. Via F. Barbarossa, 7 26824 Cavenago D'Adda Lodi;
De Salute S.r.l. via Biasini, 26 26015 Soresina Cremona;
Pharm@idea S.r.l. via del Commercio,5 25039 Travagliato (BS). Classificazione ai fini della rimborsabilita' Confezione: Guttalax «7,5 mg/ml gocce, soluzione orale»...
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