A.W.P. - S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio di una specialita' medicinale per uso umano. (Modifiche apportate ai sensi del decreto legislativo 29 dicembre 2007, n. 274 Modifiche apportate ai sensi del regolamento 1084/2003/CE).
Medicinale: AMLODIPINA AWP.
Confezione e numero di A.I.C.:
038635/M per tutte le confezioni autorizzate.
Modifica tipo IA n. 15a (MRP NL/H/1287/01-02/IA/03 - convalidata a livello europeo in data 9 giugno 2009) Presentazione di un certificato d'idoneita' della Farmacopea europea aggiornato relativo al principio attivo Amlodipina Besilato, da parte di un produttore attualmente autorizzato Glochem Industries Limited, India - R0-CEP 2005-173-Rev 04.
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