COMUNICATO - Variazione di tipo II all'autorizzazione, secondo procedura di mutuo riconoscimento, del medicinale per uso umano «Seretide». (13A07177)
Estratto determinazione V &
A/1307 del 23 luglio 2013 Specialita' Medicinale: SERETIDE Confezioni: 034371106 - "25/50 mcg sospensione pressurizzata per inalazione" 1 inalatore da 120 dosi 034371118 - "25/125 mcg sospensione pressurizzata per inalazione" 1 inalatore da 120 dosi 034371120 - "25/250 mcg sospensione pressurizzata per inalazione " 1 inalatore da 120 dosi Titolare AIC: Glaxosmithkline S.P.A. N° Procedura Mutuo Riconoscimento: UK/H/0392/001-003/II/063 UK/H/0392/001-003/IB/065 Tipo di Modifica: C.I.4 Variazioni collegate a importanti modifiche nel riassunto delle caratteristiche del prodotto, dovute in particolare a nuovi dati in materia di qualita', di prove precliniche e cliniche o di farmacovigilanza C.I.3 Attuazione della modifica o delle modifiche richieste dall'EMEA/dall'autorita' nazionale competente in seguito alla valutazione di una misura restrittiva urgente per motivi di sicurezza, dell'etichettatura di una classe, di una relazione periodica aggiornata relativa alla sicurezza, di un piano digestione del rischio, di una misura di controllo/di un obbligo specifico, di dati presentati in virtu' degli articoli 45 e 46 del regolamento (CE) n. 1901/2006 o di modifiche volte a riflettere un RCP (riassunto delle caratteristiche del prodotto) di base elaborato da un'autorita' competente a) Attuazione della o delle modifiche di testo approvate per le quali il titolare dell'autorizzazione all'immissione in commercio non presenta nuove informazioni complementari Modifica Apportata: E' autorizzata la modifica degli stampati sezioni 4.4 e 4.8 del Riassunto delle...
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