COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Lercanidipina Eg». (15A07312)
Estratto determina V&A/1769 del 15 settembre 2015 Autorizzazione della variazione: B.II.b.5.e Relativamente al medicinale: LERCANIDIPINA EG Numero procedura Europea: DE/H/0955/001/II/007 Titolare AIC: EG S.P.A. E' autorizzata la seguente variazione: Modifica delle prove in corso di fabbricazione o dei limiti applicati durante la fabbricazione del prodotto finito: Ampliamento del range dei limiti per l'in-process control "resistance to crushing": da 20-40 a 25-50 N, relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura di Mutuo riconoscimento. Smaltimento...
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