COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Zengac». (13A08122)
Estratto determinazione V &
A n. 1615 del 30 settembre 2013 Titolare AIC: FISIOPHARMA S.R.L. con sede legale e domicilio fiscale in NUCLEO INDUSTRIALE, 84020 - PALOMONTE - SALERNO (SA) codice fiscale 02580140651 Medicinale: ZENGAC Variazione AIC: B.II.d.1.e Modifica dei parametri di specifica e/o dei limiti del prodotto finito Modifica al di fuori dei limiti di specifica approvati L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata: E' autorizzata la modifica del limite di specifica del titolo della Vancomicina B e del totale delle sostanze correlate alla shelf life fuori i limiti relativamente alla Specialita' Medicinale indicata in...
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