EPIFARMA S.R.L. - Comunicazione notifica regolare UVA
Comunicazione notifica regolare UVA Specialita' Medicinale: MEXYLOR (AIC: 036336) Confezioni: 036336016 - "2,5 mg/ml gocce orali, soluzione" flacone 20 ml (Autorizzata) Titolare AIC: EPIFARMA S.r.l. N. e Tipologia variazione: C.I.3.a IB foreseen - Cod. Pratica N. N1B/2013/319 Tipo modifica: Modifica stampati - Modifica apportata:Modifica degli stampati E' autorizzata la modifica di stampati richiesta (paragrafi 2,4.2,4.3,4.4,4.5, 4.6,4.7,4.8,4.9,8 e 9 del Riassunto di Caratteristiche del Prodotto e corrispondenti paragrafi del Foglio Illustrativo ed Etichette) relativamente alle confezioni sopra elencate e la responsabilita' si ritiene affidata alla Azienda titolare dell'AIC. I lotti gia' prodotti non...
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