PENSA PHARMA S.P.A. -
Modifiche secondarie di autorizzazioni all'immissione in commercio di specialita' medicinale per uso umano. Modifiche apportate ai sensi del Decreto Legislativo 29 dicembre 2007, n. 274. Medicinale: LORMETAZEPAM PENSA Numeri A.I.C. e confezioni: 036076014 - "2,5 mg/ml gocce orali, soluzione" flacone 20 ml Titolare A.I.C.: Pensa Pharma S.p.A. Codice Pratica N.: N1B/2013/309 Tipologia variazione: IB foreseen - n. C.I.3.a Tipo di modifica: Modifica stampati Modifica apportata: Modifica stampati per implementare le avvertenze contenute nel Core Safety Profile finalizzato durante la procedura di PSUR work sharing N. AT/H/PSUR/0030/01. E' autorizzata la modifica degli stampati richiesta (paragrafi 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9 del Riassunto delle Caratteristiche del Prodotto e corrispondenti paragrafi del Foglio Illustrativo) relativamente alle confezioni sopra elencate e la responsabilita' si ritiene affidata all'Azienda titolare dell'A.I.C.. I lotti gia' prodotti non possono piu' essere dispensati al pubblico a decorrere dal 180^ giorno successivo a quello della pubblicazione della presente determinazione nella Gazzetta Ufficiale della Repubblica Italiana. Trascorso il suddetto termine non potranno piu' essere dispensate al pubblico...
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