COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Beriplast P» (13A10229)
Estratto determinazione V &
A 2082 del 25 novembre 2013 Specialita' medicinale: BERIPLAST P. Confezioni: e' autorizzata la rettifica della descrizione delle confezioni, per adeguamento agli Standard Terms: da: 035941018 - "0,5 ml polveri e solventi per colla di fibrina" polveri (flaconcini 1 e 3 ) + solventi (flaconcini 2 e 4 ) + set di ricostituzione ed applicazione;
035941020 - "1 ml polveri e solventi per colla di fibrina" polveri (flaconcini 1 e 3 ) + solventi (flaconcini 2 e 4 ) + set di ricostituzione ed applicazione;
035941032 - "3 ml polveri e solventi per colla di fibrina" polveri (flaconcini 1 e 3 ) + solventi (flaconcini 2 e 4 ) + set di ricostituzione ed applicazione;
a: 035941018 - "0,5 ml polveri e solventi per adesivo tissutale" polveri (flaconcini 1 e 3 ) + solventi (flaconcini 2 e 4 ) + set di ricostituzione ed applicazione;
035941020 - "1 ml polveri e solventi per adesivo tissutale" polveri (flaconcini 1 e 3 ) + solventi (flaconcini 2 e 4 ) + set di ricostituzione ed applicazione;
035941032 - "3 ml polveri e solventi per adesivo tissutale" polveri (flaconcini 1 e 3 ) + solventi (flaconcini 2 e 4 ) + set di ricostituzione ed applicazione. Titolare AIC: CSL Behring GmbH. Numero procedura mutuo riconoscimento: DE/H/0135/001-003/II/064/G. Tipo di modifica: B.II.d.2.a Modifica della procedura di prova del prodotto finito. Modifiche minori di una procedura di prova approvata;
B.II.d.2.c Modifica della procedura di prova del prodotto finito. Sostituzione di un metodo di prova biologico, immunologico o immunochimico o di un metodo che utilizza un reattivo biologico;
B.II.d.2.d Modifica della procedura di prova del prodotto finito. Altre modifiche di una procedura di prova;
B.III.2.b Modifica al fine di conformarsi alla farmacopea europea o alla farmacopea nazionale di uno Stato membro. Modifica al fine di conformarsi ad un aggiornamento della monografia applicabile della Farmacopea europea o della Farmacopea nazionale;
B.I.a.4 z) Modifica...
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