GLAXOSMITHKLINE CONSUMER HEALTHCARE - S.p.a.
Modifiche secondarie di un'autorizzazione all'immissione in commercio
di specialita' medicinali per uso umano. (Comunicazioni Agenzia
italiana del farmaco - Ufficio autorizzazioni all'immissione in
commercio di medicinali del 1° ottobre 2007).
Titolare: GlaxoSmithKline Consumer Healthcare S.p.a., via Zambeletti snc, Baranzate (MI).
Specialita' medicinale: RINAZINA.
Confezione e numero di A.I.C.:
"adulti gocce nasali, soluzione" flacone 10 ml - A.I.C. n. 000590012.
Modifiche apportate ai sensi del regolamento n. 1084/2003/CE:
Codice pratica: N1A/07/1074.
32.a Modifica dimensione lotti del prodotto finito fino a 10 volte la dimensione originale del lotto approvata con la concessione dell'A.I.C. da: 600 litri a: 1.000 litri.
Codice pratica: N1A/07/1076.
28 Modifica ogni parte materiale d'imballaggio primario non in contatto con il prodotto finito e conseguente; 36b Modifica della forma o delle dimensioni del contenitore o della chiusura da: capsula in alluminio munita di sigillo di garanzia aggraffato sul collo del flacone, con sovrapposta capsula esterna in polipropilene, con sistema di apertura a prova di bambino a...
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