COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Zoladex» (20A03525)
Estratto determina AAM/PPA n. 363/2020 del 26 giugno 2020 Si autorizza la seguente variazione, relativamente al medicinale ZOLADEX: tipo II, B.II.d.1 - Modifica dei parametri di specifica e/o dei limiti del prodotto finito;
f) Soppressione di un parametro di specifica tale da avere un effetto significativo sulla qualita' globale del prodotto finito. Confezioni A.I.C. n.: 026471019 - «3,6 mg impianto a rilascio prolungato per uso sottocutaneo» 1 siringa preriempita;
026471021 - «10,8mg impianto a rilascio prolungato per uso sottocutaneo» 1 siringa preriempita. Titolare A.I.C.: Astrazeneca S.p.a. (codice fiscale 00735390155). Codice pratica: VN2/2019/219. Smaltimento scorte I lotti gia' prodotti alla data di...
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