COMUNICATO - Variazione di tipo II all''autorizzazione secondo procedura di mutuo riconoscimento del medicinale «Misofenac». (10A13671)
Estratto determinazione V & A.PC/II/740 del 25 ottobre 2010
Specialita' medicinale: MISOFENAC.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare AIC: Bioindustria Farmaceutici srl.
Numero procedura di mutuo riconoscimento: UK/H/0136/001/II/003.
Tipo di modifica: presentazione/aggiornamento modulo 1.
Modifica apportata: in conformita' con quanto previsto dal CHMP, «linee guida sul rischio ambientale valutazione dei prodotti medicinali per uso umano»: presentazione della relazione sulla valutazione del rischio ambientale (ERA).
Le confezioni del medicinale devono essere poste in commercio con gli stampati, cosi' come...
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