DAIICHI SANKYO ITALIA - S.p.a.
Modifiche secondarie di autorizzazioni all'immissione in commercio
Titolare: Daiichi Sankyo Italia S.p.a., via Paolo di Dono n. 73 - 00142 Roma. Codice fiscale n. 00468270582. Modifiche apportate ai sensi del regolamento (CE) n. 1084/2003. Pratiche UPC/I/4644/2006 e UPC/I/4645/2006 del 19 settembre 2006. Provvedimento UPC/I/4879/2006 del 23 ottobre 2006. 14.a - Modifica del sito del produttore gia' approvato (sostituzione o aggiunta) se non disponibile un certificato di idoneita' della Farmacopea Europea. Aggiunta di sito di produzione del principio attivo Olmesartan (synthesis step 2): Sankyo Chemical Industries Ltd - 4-8-Nishiyawata 4-chome - Hiratsuka-shi - Kanagawa 254-0073 - Japan. 12.a - Inasprimento limiti delle specifiche di un principio attivo o materiale/inziale/ intermedio/reagente utilizzato nel processo di produzione del principio attivo. Restrizione dei limiti delle...
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