COMUNICATO - Rettifica della determina V & A n. 1842 del 30 ottobre 2013, di autorizzazione all'immissione in commercio del medicinale per uso umano «Atovaquone e Proguanile Mylan Generics». (16A08397)
Estratto determina AAM/AIC 1848/2016 del 10 novembre 2016 E' rettificata, nei termini che seguono, la determina V &
A n. 1842 del 30 ottobre 2013, concernente l'autorizzazione all'immissione in commercio del medicinale ATOVAQUONE E PROGUANILE MYLAN GENERICS nelle forme e confezioni: AIC n. 040697017 - «250 mg/100 mg compresse rivestite con film» 12 compresse in blister pvc/al;
AIC n. 040697029 - «250 mg/100 mg compresse rivestite con film» 12 compresse in blister opa/al/pvc-al;
AIC n. 040697031 - «250 mg/100 mg compresse rivestite con film» 12 compresse in blister pvc/pvdc-al;
AIC n. 040697043 - «250 mg/100 mg compresse rivestite con film» 12 compresse in blister monodose pvc/al;
AIC n. 040697056 - «250 mg/100 mg compresse rivestite con film» 12 compresse in blister monodose opa/al/pvc-al;
AIC n. 040697068 - «250 mg/100 mg compresse rivestite con film» 12 compresse in blister monodose pvc/pvdc-al il cui estratto e' stato pubblicato nella Gazzetta Ufficiale della Repubblica italiana - Serie generale n. 273 del 21 novembre 2013. All'art. 1 nella parte dispositiva della determinazione sopra riportata, al paragrafo «Produttore del prodottto finito», nonche' al punto 6 del foglio illustrativo...
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