ratiopharm Italia - S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano. (Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007, n. 274 - Modifica apportata ai sensi del regolamento n. 1084/2003/CE).
Medicinale: AMIODARONE ratiopharm Italia.
Confezione e numero di A.I.C.:
'200 mg compresse' 20 compresse - A.I.C. n. 035729019.
Variazione Tipo IB n. 15b2 Presentazione di un certificato d'idoneita' della Farmacopea europea aggiornato relativo al principio attivo Amiodarone Cloridrato da parte del nuovo produttore Glenmark Generics LTD - R0-CEP 2003-216-Rev 03.
I lotti gia' prodotti alla data della pubblicazione nella Gazzetta Ufficiale...
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