Arrow Generics Ltd
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).
Specialita' medicinale: AMLODIPINA ARROW.
Confezioni e numeri di A.I.C.:
A.I.C. n. 037706/M per tutte le confezioni autorizzate.
Modifica tipo IA n. 15a (MRP n. UK/H/0862/01/IA/08, convalida a livello europeo in data 2 dicembre 2008) consistente nella presentazione di un certificato d'idoneita' della Farmacopea europea aggiornato (R0-CEP 2005-237-Rev 02) relativo al p.a. Amlodipina Besilato, da parte del produttore Moehs Iberica S.L., Spagna.
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