Otifarma S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio di medicinale per uso umano. Modifica apportata ai sensi del D.Lgs 29 dicembre 2007, n. 274.
Titolare: Otifarma S.r.l.- via Assarotti, 7 - 10122 Torino.
Medicinale SPASMODENE Confezioni e numeri A.I.C: '10 mg Compresse rivestite' 30 Compresse AIC n. 029108014; 20 mg Compresse rivestite' 30 Compresse AIC n. 029108026; '10 mg Soluzione Iniettabile' 6 Fiale da 1ml AIC n. 029108038; '60 mg supposte' 6 supposte AIC n.
029108040. Modifica apportata ai sensi del Regolamento (CE) 1084/2003: Variazione di tipo IB (14 b). Modifica del produttore del principio attivo qualora non sia disponibile un certificato di idoneita' della Farmacopea Europea (sostituzione): DA Istituto Biologico Chemioterapico...
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