COMUNICATO - Modificazione dell''autorizzazione all''immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale «Ciprofloxacina Kabi».
Estratto provvedimento UPC/II/595 del 21 ottobre 2008
Specialita' Medicinale: CIPROFLOXACINA KABI.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C: FRESENIUS KABI ITALIA S.p.a.
Numero procedura mutuo riconoscimento: NL/H/0695/001-003/II/004.
Tipo di modifica: aggiornamento metodica chimica/farmaceutica
Modifica apportata: aumento del batch size da 1500 litri a 5000 litri
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