Therabel Gienne Pharma S.p.A.
Modifica secondaria di un'autorizzazione all'immissione in commercio di un medicinale per uso umano. Modifica apportata ai sensi del decreto legislativo 29 dicembre 2007, n. 274.
Titolare: Therabel GiEnne Pharma SpA - Via Lorenteggio 270/A Milano Specialita' medicinale: LEVOBREN Confezione e numero di AIC:
25 mg compresse - 20 compresse (AIC 027210018) - 50 mg compresse - 20 compresse (AIC 027210020) - 100 mg compresse - 20 compresse (AIC 027210032) Modifica apportata ai sensi del Regolamento 1084/2003/CE.
Variazione Tipo IA n. 38a: Modifica di una procedura di prova del prodotto finito gia' approvata (Metodo HPLC) Confezione e numero di AIC:
25 mg/ml gocce orali, soluzione - flacone contagocce 20 ml A.I.C. 027210069
Modifica apportata ai sensi del Regolamento 1084/2003/CE.
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Variazione Tipo IA n. 38a: Modifica minore di una procedura di prova approvata. Metodo HPLC per la determinazione del metil-p-idrossibenzoato.
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Variazione Tipo IA n. 38a: Modifica minore di una procedura di prova approvata. Metodo HPLC per la determinazione del...
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