ratiopharm Italia - S.r.l.
Modifica secondaria di un'autorizzazione all'immissione in commercio
di medicinale per uso umano. Modifica apportata ai sensi del
regolamento (CE) n. 1084/2003.
(Comunicazione AIFA del 15 ottobre 2007). Codice pratica: N1A/07/1057.
Specialita' medicinale: PIROXICAM RATIOPHARM.
Confezioni e numeri di A.I.C.:
"20 mg capsule rigide" 30 capsule - A.I.C. n. 031222021;
"20 mg compresse solubili" 30 compresse- A.I.C. n. 031222033.
Modifica n. 9: Eliminazione del sito Doppel Farmaceutici S.r.l., Piacenza relativamente a tutte le fasi di produzione, inclusi il confezionamento primario e secondario, il controllo ed il rilascio dei lotti.
(Comunicazione AIFA del 15 ottobre 2007). Codice pratica: N1B/07/1049.
Confezioni e numeri di A.I.C.:
"20 mg/ml soluzione iniettabile per uso intramuscolare" 6 fiale - A.I.C. n. 031222019.
Modifica n. 37b e conseguente 38c: Aggiunta del parametro di prova "Assay: nicotinamid" alle specifiche al rilascio ed al termine del periodo di validita' del prodotto finito. Il limite di accettabilita' corrisponde al range 95.0-105.0% (28.50 mg/ml-31.50mg/ml). Con la presente si approva anche la sostituzione del metodo HPLC che permette l'identificazione ed il titolo del Piroxicam e della Nicotinamide nel prodotto finito.
(Comunicazione AIFA del 15 ottobre 2007). Codice pratica: N1B/07/1048.
Modifica n. 37b e conseguente 38c: Aggiunta del parametro di prova "Purity test Piroxicam: 2-aminopyridine, any unidentified impurity, total unidentified impurity" e del parametro di prova "Purity test Nicotinamide: nicotin acid, any...
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