COMUNICATO - Variazione di tipo II all''autorizzazione all''immissione in commercio, secondo procedura di mutuo riconoscimento, del medicinale « Rinelon ». (11A06456)
Estratto determinazione V & A.PC/II/260 del 19 aprile 2011
Specialita' medicinale: RINELON.
Confezioni: relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di mutuo riconoscimento.
Titolare A.I.C.: Istituto Farmacobiologico Malesci S.p.a.
Numero procedura mutuo riconoscimento: UK/H/0196/001/II/038.
Tipo di modifica: aggiornamento metodica chimica/farmaceutica.
Modifica apportata: riduzione della lunghezza del tubicino utilizzato nella presentazione da 10g, da 24.5+/-1.0mm a 23.0+/-0.8mm.
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