Merck Serono - S.p.a.
Modifica secondaria di autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. (Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007, n. 274).
Titolare: Merck KGaA, Frankfurter Strasse 250, 64923 Darmstadt Germania.
Specialita' medicinale: CONGESCOR.
Confezioni e numeri di A.I.C.:
tutte le confezioni - A.I.C. n. 034953/M:
1,25 mg, 2,5 mg, 3,75 mg, 5 mg, 7,5 mg e 10 mg compresse rivestite con film.
Procedura n. SE/H/0186/001-006/IB/022.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Tipo IB n. 37b: modifica di una specifica del prodotto finito, aggiunta di un nuovo parametro di procedura di prova e conseguente tipo IA n. 38a: modifica minore di una procedura di prova approvata per il prodotto finito:
introduzione dell'identificazione del prodotto di degradazione UDP3-bisoprololo-N-aldeide e coseguente aggiornamento del metodo HPLC usato per la determinazione di questa sostanza alla scadenza del periodo di validita' del prodotto finito.
Procedura n. SE/H/0186/001-006/IB/023.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
Tipo IB n. 37b: modifica di una specifica del prodotto finito, aggiunta di un nuovo parametro di...
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