ratiopharm Gmbh Rappresentante in Italia: 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: ACETILCISTEINA ratiopharm.
Confezioni e numeri di A.I.C.:
034256026 '600 mg compresse effervescenti' 30 compresse.
Variazione Tipo IA n. 15a Presentazione di un certificato d'idoneita' della Farmacopea europea aggiornato relativo al principio attivo da parte del produttore attualmente approvato Zach System S.p.a. (Acetilcisteina, R1-CEP 1996-070-Rev 04).
I lotti gia' prodotti alla data della pubblicazione nella Gazzetta Ufficiale...
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