COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Euclorina». (15A04895)
Estratto determina V&A n. 1154/2015 del 17 giugno 2015 E' autorizzata la seguente variazione: B.I.a.1.b) Modifica del fabbricante di una materia prima, di un reattivo o di un prodotto intermedio utilizzati nel procedimento di fabbricazione di un principio attivo o modifica del fabbricante del principio attivo (compresi eventualmente i siti di controllo della qualita'), per i quali non si dispone di un certificato di conformita' alla farmacopea europea Sostituzione di un fabbricante del principio attivo avente il sostegno di un ASMF (Master File del principio attivo), B.I.a.3.b) Modifica della dimensione del lotto (comprese le classi di dimensione del lotto) del principio attivo o del prodotto intermedio utilizzato nel procedimento di fabbricazione del principio attivo - Sino a 10 volte inferiore, relativamente al medicinale «EUCLORINA», nelle forme e confezioni: A.I.C. n. 032056020 - «2,5 g polvere solubile» 10 bustine;
A.I.C. n. 032056044 - «1% soluzione cutanea disinfettante» 1 flacone da 250 ml;
A.I.C. n. 032056057 - «1% soluzione cutanea disinfettante» 1 flacone da 500 ml;
A.I.C. n. 032056069 - «2,5% soluzione cutanea disinfettante» 1 flacone da 250 ml con misurino dosatore;
A.I.C. n. 032056071 - «2,5% soluzione cutanea» 1 flacone da 500 ml con misurino dosatore;
A.I.C. n. 032056083 - «2,5% soluzione cutanea disinfettante» 1 flacone da 1000 ml con misurino dosatore;
Sostituzione di D.K. Pharma Chem Pvt. Ltd come nuovo produttore per la sostanza attiva Chloramine T, e relativo batch size, come di seguito riportato: ===================================================================== | Da | A | +======================================+============================+ | | 3.2.S.2 Produttore di | | 3.2.S.2 Produttore di principio |principio attivo Chloramine | |attivo Chloramine T Axentive Tianjin |T D.K. Pharma Chem Pvt. Ltd.| | Tiancheng Pharmaceutical Co., Ltd | W-7, MIDC, Badlapur - 421 | | Tianjin...
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