ratiopharm Italia - 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.
Specialita' medicinale: AMOXICILLINA E ACIDO CLAVULANICO RATIOPHARM ITALIA.
Confezione e numero di A.I.C.:
"875 mg + 125 mg polvere per sospensione orale" 12 bustine - A.I.C. n. 036707014.
Comunicazione AIFA del 21 luglio 2008. Codice pratica: N1A/08/1458.
Modifica n. 15a - Presentazione del certificato d'idoneita' aggiornato della Farmacopea europea n. R1-CEP 2001-123-Rev 00, relativo al P.A. Amoxicillina Triidrato, da parte del produttore attualmente approvato Antibioticos SA, Avda de Antibioticos Leon-Spagna.
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