Laboratori Alter - S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio
di un medicinale per uso umano. Modifica apportata ai sensi del
regolamento (CE) n. 1084/2003 (legge 24 dicembre 2003, n. 350) e
Determinazione A.I.C./N/V n. 2174 del 5 ottobre 2007.
Specialita' medicinale: AMOXICILLINA E ACIDO CLAVULANICO ALTER.
Confezione e numero di A.I.C.:
" 875 mg + 125 mg compresse rivestite con film", 12 compresse - A.I.C. n. 036944027.
Modifica del tipo "Umbrella variation", tipo n. 32a, 33, 36b, 7a, 7b1, 7c, 8b2: aggiunta dell'officina Reig Jofre' SA sita in Calle Jarama s/n Poligono Industrial, Toledo (Spagna) per le fasi di produzione, confezionamento primario e secondario (compresa applicazione di bollini ottici), controllo e rilascio dei lotti; aggiunta della dimensione del lotto standard industriale da 336.000 compresse per l'officina Reig Jofre'; modifica del processo di produzione del prodotto finito per l'officina Reig Jofre': miscelazione degli eccipienti a granulometria diversa aggiunti in step diversi, miscelando piu' volte con tempi inferiori; modifica della forma del blister per l'officina Reig Jofre': 6 compresse/blister (2 blister); modifica della specifica "spessore della compressa": 7,20-7,80 mm per la compressa prodotto da Reig Jofre').
Determinazione A.I.C./N/V n. 2173 del 5 ottobre 2007.
Specialita' medicinale: AMOXICILLINA E ACIDO CLAVULANICO ALTER.
Confezione e numero di A.I.C.:
"875 mg + 125 mg polvere per sospensione orale", 12 bustine - A.I.C. n. 036944015.
Modifica del tipo "Umbrella variation", tipo n. 32a, 33, 36b, 7a, 7b1, 7c, 8b2: aggiunta dell'officina Reig Jofre' SA sita in Calle...
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