COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Selesyn». (15A03370)
Estratto determina V&A n. 666/2015 del 2 aprile 2015 Autorizzazione della variazione relativamente al medicinale SELESYN. E' autorizzata la seguente variazione: l'RMS esprime parere favorevole al seguente grouping: estensione dei limiti delle specifiche di fine vita «content selenium» e «extractable volume» per il prodotto finito;
estensione della shelf life del prodotto finito da 2 a 3 anni;
restringimento dei limiti delle specifiche «appearance» e «identity selenium» per il prodotto finito;
aggiunta dei nuovi parametri di specifica «absolute density», «uniformity of dosage units» e «loss of water» e dei corrispondenti metodi per il prodotto finito;
eliminazione dei parametri di specifica non significativi «relative density» e «uniformity of mass» per il prodotto finito;
modifiche minori ai metodi approvati per i parametri di specifica «osmolality» e «sodium content» per il prodotto finito. relativamente alla specialita' medicinale ed alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo...
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