LPB Istituto Farmaceutico - S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio
di specialita' medicinale per uso umano. (Comunicazione Agenzia italiana del farmaco del 26 marzo 2008). Codice pratica: N1B/08/355.
Titolare: LPB Istituto Farmaceutico S.r.l., largo Umberto Boccioni n. 1, 21040 Origgio (VA).
Specialita' medicinale: DESFERAL.
Confezione e numero di A.I.C.:
"500 mg/5 ml polvere e solvente per soluzione iniettabile" 10 flaconi + 10 fiale 5 ml - A.I.C. n. 020417022.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003: 31.b Aggiunta di nuovi limiti e prove in corso di lavorazione applicati durante la produzione del medicinale.
Modifica di una procedura di prova o dei limiti in process applicati durante la produzione di medicinale: aggiunta di una procedura di prova.
Da: ispezione visiva mediante operatore (100%).
A: ispezione visiva mediante operatore (100%) o in alternativa...
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