NOVARTIS FARMA - S.p.a.
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. (Comunicazione Agenzia italiana del farmaco del: 27 luglio 2006). Codice pratica: N1A/06/611.
Titolare: Novartis Farma S.p.a., largo Umberto Boccioni n. 1, 21040 Origgio (VA).
Specialita' medicinale: SANDOSTATINA.
Confezione e numero di A.I.C.:
'1 mg/5 ml soluzione iniettabile' 1 flacone - A.I.C. n. 027083043.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 38.a Modifica minore della procedura di prova approvata del prodotto finito.
Modifica del metodo GLC per l'identificazione e il dosaggio del fenolo: identificazione: restringimento delle deviazioni del tempo di ritenzione a +/-2% dosaggio: aumento delle replicazioni da 3 a 5 con DS...
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