COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Aulin». (15A06442)
Estratto determina V&A n. 1493/2015 del 28 luglio 2015 Autorizzazione della variazione relativamente al medicinale AULIN. E' autorizzata la seguente variazione: Introduzione del Risk Management Plan e del sommario del sistema di farmacovigilanza, relativamente alla specialita' medicinale ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo Riconoscimento. Procedura: IE/H/0116/001/II/008/G Tipologia della variazione: C.I.11.b) C.I.8.a) Titolare AIC: Helsinn Birex Pharmaceuticals LTD. Smaltimento scorte I lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza del...
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