JENSON PHARMACEUTICAL SERVICES LTD -
Modifica secondaria di un'Autorizzazione all'Immissione in commercio di una specialita' medicinale per uso umano. Modifica apportata ai sensi del Decreto legislativo 29/12/2007, n. 274. Procedura Europea n. NL/H/1878/01/IB/04 Codice pratica n. C1B/2012/2757 Specialita' Medicinale: RISEDRONATO JENSON PHARMACEUTICAL SERVICES Confezioni: Autorizzazione All'immissione in Commercio n. 041186/M - tutte le confezioni autorizzate Titolare AIC: Jenson Pharmaceutical Services Ltd Tipologia variazione: C.I.3. a Tipo IB Tipo di Modifica Modifica degli stampati Modifica Apportata: Aggiornamento RCP e FI in linea con le raccomandazioni del PhVWP e del CMDh sul rischio di cancro esofageo e l'uso di risedronato e con il QRD template. E' autorizzata la modifica degli stampati richiesta (paragrafi 2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9...
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