COMUNICATO - Variazione di tipo II all''autorizzazione secondo procedura di mutuo riconoscimento del medicinale «Omeprazolo Teva». (11A00362)
Estratto determinazione V & A.PC/II/959 del 13 dicembre 2010
Specialita' medicinale: OMEPRAZOLO TEVA.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: Teva Italia S.r.l.
Numero procedura mutuo riconoscimento: NL/H/0974/001-002/II/005.
Tipo di modifica: aggiornamento metodica chimica/farmaceutica.
Modifica apportata: correzione alla sez. 3.2.p.5.1: rivalidazione dei metodi analitici MA003 (settima edizione) e MA004 (nona edizione) e rivalidazione del metodo MA027 (quinta edizione) in seguito in...
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