COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Gamibetal Complex». (13A08116)
Estratto determinazione V &
A n. 1609 del 30 settembre 2013 Titolare AIC: Laboratorio Farmaceutico SIT Specialita' Igienico Terapeutiche S.r.l. con sede legale e domicilio fiscale in via Cavour, 70 - 27035 Mede (Pavia), codice fiscale 01108720598. Medicinale: GAMIBETAL COMPLEX. Variazione AIC: B.I.a.1 z) Modifica del fabbricante di una materia prima, di un reattivo o di un prodotto intermedio utilizzato nel procedimento di fabbricazione di una sostanza attiva o modifica del fabbricante della sostanza attiva (compresi, eventualmente, i siti di controllo della qualita'), per i quali non si dispone di un certificato di conformita' alla farmacopea europea - Altra variazione Adeguamento Standard Terms. L'autorizzazione all'immissione in commercio e' modificata come di seguito indicata. E' autorizzata la modifica come di seguito riportato: Parte di provvedimento in formato grafico Retest period: 24 mesi relativamente alla specialita' medicinale indicata in oggetto e alle confezioni sotto elencate: 020225025 - «250 mg compresse» 30 compresse. E' inoltre modificata, secondo l'adeguamento...
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