MSD ITALIA S.R.L. - Estratto Comunicazione notifica regolare UVA per la pubblicazione in Gazzetta Ufficiale della Repubblica Italiana
Estratto Comunicazione notifica regolare UVA per la pubblicazione in Gazzetta Ufficiale della Repubblica Italiana Specialita' medicinali: NEO-LOTAN PLUS 50 mg + 12,5 mg e 100 mg + 25 mg compresse rivestite con film Confezioni: 032993014, 032993038, 032993040, 032993053 Titolare AIC: MSD Italia S.r.l. N° e Tipologia variazione: NL/H/1458/001-003/WS/018 (NL/H/xxxx/WS/034) C.I.3. IB forseen Codice Pratica N° C1B/2012/1701 Tipo di modifica: Modifica stampati Modifica apportata: Modifica degli stampati a seguito del PhVWP sull'uso di Losartan in combinazione con idroclorotiazide e adeguamento al QRD template. E' autorizzata la modifica degli stampati richiesta (paragrafi 4.2,4.3, 4.4, 4.5, 4.6, 4.8,5.1, 5.2, 5.3, 9) del Riassunto delle Caratteristiche del Prodotto e corrispondenti paragrafi del Foglio Illustrativo e delle etichette, relativamente alle confezioni sopra...
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