JANSSEN-CILAG - S.p.a.
Modifica secondaria di un'autorizzazione all'immissione in commercio
di specialita' medicinale per uso umano. (Comunicazione Agenzia italiana del farmaco del 19 gennaio 2007 e 22 gennaio 2007). Codice
pratica: N1B/06/588-589-590-591-592-593-594-595.
Titolare: Janssen-Cilag S.p.a., via M. Buonarroti n. 23, 20093 Cologno Monzese (MI).
Specialita' medicinale: HALDOL.
Confezione e numero di A.I.C.:
2 mg/ml gocce orali, soluzione - flacone da 30 ml - A.I.C. n. 025373059.
Modifica apportata ai sensi del regolamento (CE) n. 1084/2003:
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c Altre modifiche di una procedura di prova del prodotto finito, inclusa la sostituzione o l'aggiunta di una procedura di prova:
Sostituzione del metodo HPLC per l'identificazione e il titolo del principio attivo e per il titolo del metilparaidrossibenzoato al rilascio e al termine del periodo di validita': da HPLC a HPLC (AMD_PLCS_2029_01000);
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c Altre modifiche di una procedura di prova del prodotto finito, inclusa la sostituzione o l'aggiunta di una procedura di prova e conseguente 37.a Inasprimento dei limiti delle specifiche del prodotto finito:
Restrizione della specifica per il secondo test di identificazione del principio attivo nel prodotto finito al rilascio: da positivo a confronto tra la lunghezza d'onda della soluzione standard e della soluzione test (+/- 2nm). Sostituzione del relativo metodo da TLC a DAD (AMD_PLCS_2029_01000);
Modifica dei limiti di terminazione dei composti di degradazione al termine del periodo di validita'. Da assente a: impurezze singole non specifiche 0.2%; totali 0.5%. Modifica del metodo da TLC a HPLC (AMD_PLCS_2029_01000);
Modifica della specifica per i controlli microbiologici al termine del periodo di validita' e del conseguente metodo (secondo Ph.Eur. edizione corrente);
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b Aggiunta di un nuovo parametro di prova alle specifiche del prodotto finito e conseguente 38.c Altre modifiche di una...
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