Modificazione dell'autorizzazione all'immissione in commercio della - specialita' medicinale per uso umano "Borocaina"
Estratto provvedimento di modifica di A.I.C. n. 402 del 6 luglio 1998 Specialita' medicinale: BOROCAINA, 30 compresse, A.I.C. n.
004901029.
Societa': Alfa Wassermann S.p.a., contrada Sant'Emidio - 65020 Alanno (Pescara).
Oggetto provvedimento di modifica: nuova confezione - in sostituzione; modifica eccipienti; prolungamento della durata di validita' del prodotto.
La composizione e' cosi' modificata: principio attivo invariato; eccipienti: saccarosio 1,495 mg, glucosio 1,224 mg, essenza menta 5,81 mg, mentolo 6,78 mg, eucaliptolo 6,78 mg, indigotina (E132) 0,11 mg, giallo tartrazina (E102) (eliminato), estratto di curcumina (E100) 1,12 mg.
E' altresi' autorizzata la modifica della confezione nonche', in adeguamento...
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