COMUNICATO - Rettifica della determina V&A n. 1978 del 14 ottobre 2015, relativa alla modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Actigrip Gola». (16A01079)
Estratto determina V&A n. 143 del 26 gennaio 2016 E' rettificato, nei termini che seguono, l'estratto alla determina V&A n. 1978 del 14 ottobre 2015, pubblicato nella Gazzetta Ufficiale - serie generale - n. 252 del 29 ottobre 2015, relativamente al medicinale ACTIGRIP GOLA. Laddove e' riportato: «C.I.4) Una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati sulla qualita', preclinici, clinici o di farmacovigilanza, relativamente al medicinale ACTIGRIP GOLA. E' autorizzato l'aggiornamento del riassunto delle caratteristiche del prodotto, del foglio Illustrativo, relativamente al medicinale ACTIGRIP GOLA, nella forma e confezione sottoelencata: A.I.C. n. 019971086 - "100 mg/100 ml collutorio" 1 flacone 200 ml», leggasi: «C.I.4) Una o piu' modifiche del riassunto delle caratteristiche del prodotto, dell'etichettatura o del foglio illustrativo in seguito a nuovi dati sulla qualita', preclinici, clinici o di farmacovigilanza e la Variazione C.I.z) Altre variazioni...
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