COMUNICATO - Rettifica all'estratto della determina n. 185/2020 del 12 febbraio 2020, concernente la modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Vesanoid». (20A02029)
Estratto determina n. 311/2020 del 26 marzo 2020 Medicinale: VESANOID. E' integrato l'estratto, nei termini che seguono, della determina AIFA n. 185/2020 del 12 febbraio 2020 di modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Vesanoid», pubblicata, per estratto, nella Gazzetta Ufficiale della Repubblica italiana - Serie generale - n. 46 del 24 febbraio 2020. All'interno della sezione «Stampati», all'inciso: «Le confezioni della specialita' medicinale devono essere poste in commercio con etichette e fogli illustrativi conformi al testo allegato alla presente determina. E' approvato il riassunto delle caratteristiche del prodotto allegato alla presente determina» e' aggiunta la seguente locuzione iniziale: «Tenuto conto della variazione approvata dall'AIFA con codice VC2/2015/735 (procedura FR/H/xxxx/WS/052)»;
dopo la sezione «Stampati» e' inserita la seguente sezione: «(Smaltimento scorte) Ai sensi dell'art. 1, comma 2, della determina AIFA n. 821/2018 del 24 maggio 2018 (Criteri per l'applicazione delle disposizioni relative allo smaltimento delle scorte dei medicinali ai sensi dell'art. 1, comma 164, della legge 4 agosto 2017, n. 124)...
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