MERCK GENERICS ITALIA - S.p.a.
Modifica secondaria di un'autorizzazione all'immissione in commercio
di un medicinale per uso umano. (Modifica apportata ai sensi del
regolamento (CE) n. 1084/2003, legge 24 dicembre 2003, n. 350).
Specialita' medicinale: DILTIAZEM MERCK GENERICS ITALIA.
Confezione e numero di A.I.C.:
"60 mg compresse" 50 compresse - A.I.C. n. 026675013.
Comunicato AIFA del 26 settembre 2007. Codice pratica n. N1B/07/886.
Modifica n. 30b: Sostituzione del fornitore della lamina PVC: da Caleppiovinil S.p.a., 38026 Fucine di Ossana (TN) a Lamp San Prospero S.r.l., via della Pace n. 25/a, 41030 San Prospero (MO). Sostituzione del fornitore del foglio di alluminio laccato da: Conter, via Spallanzani n. 3, Rolo (RE) a: Lamp San Prospero S.r.l., via della Pace n. 25/a, 41030 San Prospero (MO).
Comunicato AIFA del 26 settembre 2007. Codice pratica n. N1B/07/900.
Modifica n. 37b e conseguente 38c: Aggiunta del parametro di prova "impurities" (HPLC): each known impurity, each unknown impurity, total impurities" con relativo metodo HPLC impiegato per la determinazione, alle specifiche, al rilascio ed al termine del periodo di validita' del prodotto finito. I limiti di accettabilita' sono i seguenti: each known impurity: NMT 0.5%; each unknown impurity: NMT 0.1%; Total impurities: 1.0%.
Comunicato AIFA del 26 settembre 2007. Codice pratica n. N1B/07/887.
Modifica n. 37a: Inasprimento dei limiti della specifica "dissolution test" al rilascio ed al termine del periodo di validita' del prodotto finito: da "NMT 60% dopo 30 minuti NLT 75% dopo 3 ore" a "NMT 60% (Q=60%) dopo 30 minuti NLT 80% (Q=75%) dopo 3 ore".
Comunicato AIFA del 21 settembre 2007. Codice pratica n. N1B/07/1535.
Specialita' medicinale: LEXOSEDIN.
Confezioni e numeri di A.I.C.:
"2 mg/ml gocce orali, soluzione" flacone 15 ml con contagocce - A.I.C. n. 035117011;
"1,7 mg/5 ml sciroppo" flacone 125 ml con misurino - A.I.C. n. 035117023.
Modifica n. 2: modifica del nome del prodotto...
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