Bausch & Lomb Iom S.P.A.
Modifiche secondarie di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano. (Modifiche approtate ai sensi del decreto legislativo 29 dicembre 2007, n. 274).
Titolare: Bausch & Lomb IOM S.p.A., Via Pasubio 34, 20050 Macherio (MI) Medicinale: Lotemax.
Confezioni e numeri di A.I.C.: 036668010/M, 5mg/ml collirio sospensione flacone da 2,5 ml - A.I.C. n. 036668022/M, 5mg/ml collirio sospensione flacone da 5 ml - A.I.C. n. 036668022/M, 5mg/ml collirio sospensione flacone da 10 ml - A.I.C. n. 036668046/M, 5mg/ml collirio sospensione flacone da 15 ml.
Procedura di MRP n. UK/H/0629/001/IB/011
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Modifica tipo IB - n. 25 a2: modifica apportata per essere in conformita' alle specifiche di farmacopea europea per l'eccipiente benzalconio cloruro: da FN a Ph.Eur.
Procedura di MRP n. UK/H/0629/001/IB/012
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Modifica IB - n. 18: modifica apportata per sostituire l'eccipiente glicerina: da grado sintetico a base-vegetale.
Procedura di MRP n. UK/H/0629/001/IB/013
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Modifica IB - n. 33: modifica minore della produzione del prodotto finito: sistema alternativo per trasferire il prodotto in sospensione alla linea di...
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