ITALCHIMICI - S.p.a.
Modifica secondaria di un'autorizzazione all'immissione in commercio di specialita' medicinale per uso umano. (Comunicazioni Ministero della salute - Dipartimento valutazione medicinali e farmacovigilanza). PERIDON Supposte Adulti e Bambini Cod. pratiche: N1B/08/878, N1B/08/879, N1A/08/1116 del 12 giugno 2008, modifiche apportate ai sensi del regolamento (CE) n. 1084/2003.
Specialita' medicinali: PERIDON.
Confezioni e numeri di A.I.C.:
Adulti 60 mg supposte 6 supposte - A.I.C. n. 024309041;
Bambini 30 mg supposte, 6 supposte - A.I.C. n. 024309066 Codice pratica N1B/08/878.
Modifica: 37.b Modifica delle specifiche del prodotto finito per aggiunta del parametro di procedura di prova "uniformita' delle unita' di dosaggio" al rilascio del prodotto e conseguente introduzione del metodo analitico previsto dalla corrente edizione della Farmacopea europea. Codice pratica N1B/08/879.
Modifica: 37.b Modifica delle specifiche del prodotto finito per aggiunta del parametro di procedura di prova "Identificazione BHA" al rilascio e conseguente introduzione del metodo analitico HPLC. Codice...
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