COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Viruxan». (15A06445)
Estratto determina V&A n. 1502/2015 del 28 luglio 2015 Autorizzazione della variazione relativamente al medicinale VIRUXAN. E' autorizzata la seguente variazione: B.I.a z) Modifiche qualitative del principio attivo, fabbricazione - altra variazione, relativamente al medicinale «VIRUXAN», nelle forme e confezioni: AIC n. 024055028 - 40 compresse 500 mg;
AIC n. 024055030 - «5% sciroppo" flacone 120 ml;
AIC n. 024055055 - os 20 bust. 1 g;
AIC n. 024055093 - crema 20 g 20%;
AIC n. 024055131 - 10 bustine vaginali g 10;
AIC n. 024055168 - im iv 10 fiale 1 g/5 ml;
AIC n. 024055170 - 12 ovuli vaginali 1500 mg aggiornamento dell'ASMF del produttore Clarochem Ireland Limited (da versione 3.0 a 4.0), per il principio attivo Inosina acedoben dimepranolo (metisoprinolo/isoprinosina). E' autorizzata la rettifica dello standard terms e della descrizione della confezione: AIC n. 024055028 da: 40 compresse 500 mg a «500 mg compresse» 40 compresse in blister AIC n. 024055055 da: os 20 bust. 1 g a «1 g granulato per soluzione orale» 20 bustine;
AIC n. 024055093 da: crema 20 g 20% a «20% crema» 1 tubo da 20 g;
AIC n. 024055131 da: 10 bustine vaginali g 10 a «5 g granulato per soluzione vaginale» 10 bustine;
AIC n. 024055168 im iv 10 fiale 1 g/5 ml a «1 g/5 ml soluzione iniettabile per uso endovenoso e...
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