COMUNICATO - Autorizzazione all'importazione parallela del medicinale per uso umano «Peptazol» (18A04369)
Estratto determina IP n. 466 del 7 giugno 2018 E' autorizzata l'importazione parallela del medicinale CONTROLOC 20, gastro-resistant 28 tablets;
20 mg dalla Polonia con numero di autorizzazione 4787, intestato alla societa' Takeda Pharma SP. z o.o.e prodotto da Takeda GmbH (DE) con le specificazioni di seguito indicate a condizione che siano valide ed efficaci al momento dell'entrata in vigore della presente determina. Importatore: GMM Farma S.r.l. con sede legale in via Lambretta, 2 - 20090 Segrate (Milano). Confezione: PEPTAZOL 14 compresse gastroresistenti 20 mg in blister - Codice A.I.C. n.: 043710045 (in base 10), 19PXLX (in base 32). Forma farmaceutica: compresse. Composizione: ogni compressa gastroresistente contiene principi attivi: pantoprazolo 20 mg;
eccipienti: nucleo: sodio carbonato anidro, mannitolo (E42lL crospovidone, povidone K90, calcio stearato;
rivestimento: ipromellosa, povidone K25, titanio diossido (E17lL ossido di ferro giallo (E 172L glicole propilenico, acido metacrilico-etilacrilato copolimero (1:1L polisorbato 80, sodio laurilsolfato, trietilcitrato;
inchiostro di stampa: gommalacca, ossido di ferro rosso, nero e giallo (E172L Ammoniaca soluzione concentrata. Indicazioni terapeutiche «Peptazol» e' indicato negli adulti ed adolescenti di 12 anni ed oltre per: malattia da reflusso gastroesofageo sintomatica;
trattamento a lungo termine e prevenzione delle recidive delle esofagiti da reflusso. «Peptazol» e' indicato negli adulti per: prevenzione delle ulcere gastroduodenali indotte da farmaci antiinfiammatori non steroidei (FANS) non selettivi in pazienti a rischio che necessitano di un trattamento continuativo con FANS. Officine di confezionamento secondario: Pharma Partners S.r.l., via E. Strobino, 55/57 - 59100 Prato;
De Salute S.r.l., via...
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