BOEHRINGER INGELHEIM ITALIA S.P.A. - Modifiche secondarie di autorizzazioni all'immissione in commercio di medicinali per uso umano. Modifiche apportate ai sensi del regolamento n.1234/2008/CE.
Modifiche secondarie di autorizzazioni all'immissione in commercio di medicinali per uso umano. Modifiche apportate ai sensi del regolamento n.1234/2008/CE. Titolare: BOEHRINGER INGELHEIM ITALIA S.p.A. Via Lorenzini, 8 - 20139 Milano Specialita' medicinale: MUCOSOLVAN Confezione e numero AIC: "30 mg/5 ml sciroppo" - tutte le confezioni AIC n. 024428 Codice pratica: N1B/2012/2471 Specialita' medicinale: MUCOSOLVAN Confezione e numero AIC: "15 mg/5 ml sciroppo aroma frutti di bosco" - flacone da 200 ml AIC n. 024428272 Codice pratica: N1B/2012/2472 Modifica apportata: grouping of variations: var. tipo IB unforeseen B.II.c.1.z: modifica delle specifiche dell'eccipiente Aroma vaniglia;
var. tipo IB B.II.c.2.d: sostituzione di una procedura di prova per l'eccipiente...
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