SELVI LABORATORIO BIOTERAPICO - S.p.a.
Codice fiscale n. 10717650153
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. (Comunicazione Agenzia italiana del farmaco del 5 marzo 2006.) Codice pratica N1B/05/2121.
Titolare: Selvi Laboratorio Bioterapico S.p.a., via Procoio n. 28, 00065 Fiano Romano (RM).
Specialita' medicinale: MONOS.
Confezione e numero di A.I.C.:
'200 mg compresse rivestite con film' 6 compresse - A.I.C.: 028048066.
Modifiche apportata ai sensi del regolamento (CE) n. 1084/2003: Mod. 37.b: Aggiunta di un nuovo parametro di prova alle specifiche del prodotto finito e conseguente Mod 38.c: Aggiunta della procedura di prova: da nessuna a: carica microbica; batteri aerobi NMT 1000 UFC/g - funghi NMT 1000 UFC/g - E. Coli assente in 1 g...
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