TEVA ITALIA S.R.L. - Modifiche secondarie di un'autorizzazione all'immissione in commercio di medicinali per uso umano. Modifiche apportate ai sensi del Regolamento 1234/2008/CE.
Modifiche secondarie di un'autorizzazione all'immissione in commercio di medicinali per uso umano. Modifiche apportate ai sensi del Regolamento 1234/2008/CE. Medicinale: Allopurinolo Teva Italia;
Confezioni e numeri AIC: 040180/M per tutte le confezioni autorizzate;
Codice Pratica C1B/2012/2338 Variazione UK/H/1313/01-03/IB/04 Tipo IB n. C.I.3.a Aggiornamento del Riassunto delle Caratteristiche del Prodotto e del Foglio Illustrativo in linea ai testi concordati nel PhVWP per i rischi collegati all'allopurinolo e all'induzione di reazioni cutanee gravi (paragrafi 4.4 e 4.8 del Riassunto delle Caratteristiche del Prodotto e corrispondenti...
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