FRESENIUS KABI ITALIA - S.r.l.
Modifica secondaria di alcune autorizzazioni all'immissione in
commercio di specialita' medicinali per uso umano. (Comunicazioni
Agenzia italiana del farmaco - Ufficio AIC). Codici pratiche:
N1A/08/410 - 532, N/1B/08/483 - 575 - 576 e 577.
Titolare: Fresenius Kabi Italia S.r.l., via Camagre n. 41, 37063 Isola della Scala (VR).
Specialita' medicinale: SOLAMIN.
Codice A.I.C. n. 023081:
IV - Confezioni /019 (sosp)-/021-/033 (sosp);
"Forte" IV - Confezioni /045, /058, 060 (sosp);
5 g /100 ml soluzione per infusione - Confezione /096;
7,5 g/100 ml soluzione per infusione - Confezioni /108-/110.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003 (legge 24 dicembre 2003, n. 350): 5. Modifica della ragione sociale dell'officina responsabile della produzione, del confezionamento, del controllo e del rilascio lotti del prodotto finito da Pierrel Medical Care S.p.a. (stabilimento sito in zona industriale Tito Scalo - PZ) a Novaselect S.p.a. (stabilimento sito in zona industriale Tito Scalo - PZ).
Specialita' medicinale: SINTAMIN.
Codice A.I.C. n. 029169:
soluzione per infusione - Confezioni /012(sosp)-/024-/036-/048-/051/063-/075-/087.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003 (legge 24 dicembre 2003, n. 350):
15.b.2 Presentazione certificato di idoneita' della Farmacopea europea R0-CEP 2004-086-Rev 00 da parte di Degussa Rexim-Nanning-Pharmaceutical Co., Ltd.; n. 10 Wenjiang Road, Wunning County RC-530100 Nanning Guangxi), nuovo produttore per principio attivo non sterile;
17.a Modifica periodo di re-test del principio attivo L-Alanina prodotta da Degussa Rexim da non previsto nel CEP a 4 anni.
Specialita' medicinale: VITALIPID.
Codice A.I.C. n. 027983:
"adulti concentrato per emulsione per infusione" - Confezione /016.
"bambini concentrato per emulsione per infusione" - Confezione /028.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003 (legge 24 dicembre 2003, n. 350):
37.b Aggiunta di un nuovo parametro di proceduta di prova: Relative Density...
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