COMUNICATO - Variazione di tipo II all''autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale per uso umano «Vesnar». (12A12681)
Estratto determinazione V & A/1486 del 5 ottobre 2012
Medicinale: VESNAR
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia con procedura di mutuo riconoscimento.
Titolare A.I.C.: Crinos S.p.a.
N. procedura mutuo riconoscimento: DK/H/1789/001- 003/11/007.
Tipo di modifica: altra variazione.
Modifica apportata: presentazione dell'Eu Risk Management Plan dell'acido risedronico in accordo alla decisione della commissione del 13 luglio 2011 (Art. 31 della Direttiva 2011/83/EC) sui bifosfonati.
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