COMUNICATO - Proroga smaltimento scorte del medicinale per uso umano «Lukasm». (14A04601)
Estratto determinazione V &
A/956 del 22 maggio 2014 E' autorizzato, a decorrere dal 22/05/2014, data di scadenza del termine del periodo precedentemente concesso a seguito della Determinazione V &
A/1873 del 05/11/2013 pubblicato nella Gazzetta Ufficiale della Repubblica italiana n. 274 del 22/11/2013, il mantenimento di tutte le confezioni coinvolte nella modifica autorizzata gia' immesse in commercio del medicinale LUKASM, della societa' Addenda Pharma Srl fino al 03/06/2014. Successivamente a tale data, i lotti gia' prodotti possono essere mantenuti in commercio fino alla data di scadenza del medicinale indicata in etichetta, fermo restando l'obbligo di consegna da parte dei farmacisti agli utenti, del Foglio Illustrativo aggiornato, ai sensi di quanto previsto dall'art. 1, commi 1, 2 e 3 della determina del Direttore Generale dell'AIFA concernente «Criteri per l'applicazione delle disposizioni relative allo smaltimento delle scorte dei medicinali» n. 371 del...
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