COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Remeron» (14A09861)
Estratto determina V &
A N° 2531 del 2 dicembre 2014 Autorizzazione delle variazioni: 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;
C.I.z) Altre variazioni, relativamente al medicinale REMERON;
Numeri di procedura: N° NL/H/0132/001-007/WS/052, NL/H/xxxx/WS/057 N° NL/H/0132/001-007/WS/054, NL/H/xxxx/WS/079 E' autorizzato l'aggiornamento del Riassunto delle Caratteristiche del Prodotto, del Foglio Illustrativo e delle Etichette, relativamente al medicinale REMERON, nelle forme e confezioni sottoelencate: 029444015 - " 15 mg compresse rivestite con film" 30 compresse 029444027 - "15 mg compresse rivestite con film" 60 compresse 029444039 - "15 mg compresse rivestite con film" 90 compresse 029444078 - Blister 30 compresse 45 mg 029444092 - 14 compresse film rivestite 45 mg 029444104 - 15mg/ml flacone soluzione orale da 66ml con pompa dosatrice 029444116 - 6 compresse orodispersibili da 15 mg 029444128 - 18 compresse orodispersibili da 15 mg 029444130 - 30 compresse orodispersibili da 15 mg 029444142 - 48 compresse orodispersibili da 15 mg 029444155 - 96 compresse orodispersibili da 15 mg 029444167 - 6 compresse orodispersibili da 30 mg 029444179 - 18 compresse orodispersibili da 30 mg 029444181 - 30 compresse orodispersibili da 30 mg 029444193 - 48 compresse orodispersibili da 30 mg 029444205 - 96 compresse orodispersibili da 30 mg 029444217 - 6 compresse orodispersibili da 45 mg 029444229 - 18 compresse orodispersibili da 45 mg 029444231 - 30 compresse orodispersibili da 45 mg 029444243 - 48 compresse orodispersibili da 45 mg 029444256 - 96 compresse orodispersibili da 45 mg 029444268 - "30 mg compresse rivestite con film" 14 compresse Gli stampati corretti ed approvati sono allegati alla determinazione, di cui al presente estratto. Titolare AIC: N.V. Organon, con sede legale e domicilio fiscale in OSS - Paesi Bassi, Kloosterstraat, 6, CAP 5349 AB, Olanda (NL) Stampati 1. Il...
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