SANOFI-AVENTIS - S.p.a.
Modifica secondaria di un'autorizzazione all'immissione in commercio
di specialita' medicinale per uso umano. (Comunicazione Agenzia italiana del farmaco - Ufficio IV - Autorizzazioni all'immissione in
commercio di medicinali).
Titolare: Sanofi-Aventis S.p.a., viale L. Bodio n. 37/b, Milano.
Specialita' medicinale: GARDENALE.
Confezioni e numeri di A.I.C.:
"100 mg compresse" 20 compresse - A.I.C. n. 004556015;
"50 mg compresse" 30 compresse - A.I.C. n. 004556027.
Pratica n. N1B/07/1664 del 28 novembre 2007.
37.a - Inasprimento dei limiti delle specifiche del prodotto finito.
Restringimento dei limiti della specifica "Titolo del principio attivo" del prodotto finito al rilascio ed al termine del periodo di validita': dal range 90%-110% si passa al range 95%-105%.
Pratica n. N1B/07/1665 del 28 novembre 2007.
33. - Modifica minore della produzione del prodotto finito.
Modifica minore della produzione del prodotto finito:
da: granulazione: 2 sub-lotti;
a: granulazione: 4 sub-lotti.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003 (legge 24 dicembre...
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