GERMED PHARMA S.P.A. - Modifica AIC di medicinale per uso umano, Regolamento 1234/2008/CE
Modifica AIC di medicinale per uso umano, Regolamento 1234/2008/CE Medicinale: ACIDO ALENDRONICO GERMED, AIC 037443013. Pratica NlB/2012/2539, Variazione Grouping IB/IA B.II.b.1.e, B.II.b.4.a: aggiunta sito Atlantic Pharma (Portugal) anche per produzione prodotto finito, modifica dimensione lotto (da: batch size 100.000 cpr a: batch size da 100.000 a 250.000 cpr). Medicinale: CEFTRIAXONE GERMED PHARMA AIC 036516, tutte le confezioni, Pratica N1A/2012/1923, Grouping n. 3 variazioni IA B.III.1.a.2.: aggiornamento CEP da R0-CEP 2004-119-Rev 00 a R1-CEP 2004-119-Rev 02 produttore approvato Fresenius Kabi Infectives srl (ex Ribbon srl). Medicinale: NIMODIPINA GERMED AIC 037918012, Pratica N1A/2012/1722, Grouping n. 3 variazioni IA B.III.1.a.2.: aggiornamento CEP da R0-CEP 2004-272-Rev 01 a R1-CEP 2004-272-Rev 01 produttore approvato Uquifa S.A. Medicinale: OMEPRAZOLO...
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