COMUNICATO - Rettifica della determinazione V & A n. 932 del 10 giugno 2013 relativa al medicinale per uso umano «Combistill». (14A00874)
Estratto determinazione V &
A n. 97/2014 del 21 gennaio 2014 E' rettificata, nei termini che seguono, la determinazione V &
A n. 932 del 10 giugno 2013, concernente l'autorizzazione all'immissione in commercio del medicinale «COMBISTILL», nella forma e confezione: «0,3% + 0,1% collirio, sospensione» flaconcino contagocce 5 ml, codice A.I.C. n. 041033010, il cui estratto e' stato pubblicato nella Gazzetta Ufficiale - Serie generale n. 152 del 1° luglio 2013: laddove nell'art. 1 e' riportato: Eccipienti: Benzalconio cloruro 0,1 mg;
Disodio edetato 0,1 mg;
Sodio cloruro 3 mg;
Sodio solfato 12 mg;
Tyloxapol 0,5 mg;
Sodio idrossido o Acido sulfurico (regolatore di pH) quanto basta a 5,5 pH;
Idrossietilcellulosa 2,5 mg;
Acqua depurata quanto basta a 1 ml leggasi: Eccipienti: Benzalconio cloruro 0,1 mg;
Disodio edetato 0,1 mg;
Sodio cloruro 3 mg;
Sodio solfato 12 mg;
Tyloxapol 0,5 mg;
Sodio idrossido o Acido sulfurico (regolatore di pH) quanto basta a 5,5 pH;
Idrossietilcellulosa 2,5 mg;
Acqua per preparazioni...
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