PENSA PHARMA S.P.A. - Modifiche secondarie di autorizzazioni all'immissione in commercio di specialita' medicinali per uso umano. Modifiche apportate ai sensi del Decreto Legislativo 29 dicembre 2007, n. 274.
Modifiche secondarie di autorizzazioni all'immissione in commercio di specialita' medicinali per uso umano. Modifiche apportate ai sensi del Decreto Legislativo 29 dicembre 2007, n. 274. Medicinale: PRAMIPEXOLO PENSA Numeri A.I.C. e confezioni: 040056/M - tutte le confezioni autorizzate Titolare A.I.C.: Pensa Pharma S.p.A. Codice Pratica N.: C1A/2013/204 N. di procedura: IT/H/0162/001-002/IA/008/G Modifiche apportate ai sensi del Regolamento (CE) n.1234/2008 Tipologia variazione: "Grouping of variations" 1 variazione di tipo IA n. B.III.1 a) 2: presentazione di un certificato di conformita' alla farmacopea europea aggiornato (R0-CEP 2010-328-Rev 01), per la sostanza attiva "pramipexolo dicloridrato monoidrato" da parte di un fabbricante gia' approvato (Hetero Drugs Limited). 1 variazione di tipo IA n. B.III.1 a) 2: presentazione di un certificato di conformita' alla farmacopea europea aggiornato (R0-CEP 2010-328-Rev 02), per la sostanza attiva "pramipexolo dicloridrato monoidrato" da parte di un fabbricante gia' approvato (Hetero Drugs Limited). Medicinale: RISEDRONATO PENSA Numeri A.I.C. e confezioni: 041475/M - tutte le confezioni autorizzate Titolare A.I.C.: Pensa Pharma S.p.A. Codice Pratica N.: C1A/2012/1961 N. di procedura: SE/H/0952/001-003/IA/10 Modifica apportata ai sensi del Regolamento (CE) n.1234/2008 "Single variation" variazione tipo IAIN n. C.I. z): modifiche (efficacia/sicurezza) a prodotti medicinali per uso umano e veterinario - altra modifica: introduzione del PSMF, per tutte MAs di cui Jubilant Pharmaceuticals nv e' titolare: sono escluse le confezioni autorizzate in Italia (di cui e' titolare Pensa Pharma S.p.A.) e la confezione da 35 mg autorizzata in Germania (di cui e'...
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