COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Rosuvastatina Sandoz». (18A06986)
Estratto determina AAM/PPA n. 920/2018 del 16 ottobre 2018 Si autorizza la seguente variazione Tipo II, B.I.a.1b): aggiunta di un ulteriore produttore di principio attivo (rosuvastatin calcium) supportato da un ASMF, relativamente alla specialita' medicinale ROSUVASTATINA SANDOZ, nelle forme e confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura decentrata. Numero procedura: worksharing PT/H/XXXX/WS/003 Titolare A.I.C.: Sandoz S.p.A. (codice SIS 1392). Smaltimento scorte Sia i lotti gia' prodotti alla data di pubblicazione nella Gazzetta Ufficiale della Repubblica italiana...
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