Dentsply Italia - 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 e del regolamento n. 1084/2003/CE).
Titolare A.I.C.: Dentsply Italia S.r.l., via Curtatone n. 3, 00185
Roma.
Medicinale: ORAQIX.
Codice A.I.C. n. 037590/M.
Confezioni: tutte le confezioni autorizzate.
Modifica tipo IB n. 24 (MRP n. SE/H/426/01/IB/12 conclusa in data 26 maggio 2009). Modifica della sintesi o del recupero di un eccipiente non inserito nella Farmacopea (qualora descritti nel dossier).
Modifica dell'indirizzo del sito di purificazione del polossamero 188 e del polossamero 407, da 'Glatt Ingenierutechnik GmbH (GIT Pharma), Nordstreasse 12, 99427 Weimar, Germany, or equivalent 'a' a division of Glatt Ingenierutechnik GmbH (GIT Pharma). lPC Process-Center GmbH &...
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