COMUNICATO - Proroga smaltimento scorte del medicinale per uso umano «Tacrolimus Mylan Generics». (14A04597)
Estratto determinazione V &
A/ 946 del 22 maggio 2014 E' autorizzato, a decorrere dall'11 maggio 2014, data di scadenza del termine del periodo precedentemente concesso a seguito della determinazione V &
A/499 del 7 marzo 2014 pubblicata nella Gazzetta Ufficiale della Repubblica Italiana n. 81 del 7 aprile 2014, il mantenimento di tutte le confezioni coinvolte nella modifica autorizzata gia' immesse in commercio del medicinale TACROLIMUS MYLAN GENERICS, della societa' Mylan S.p.a. fino al 3 giugno 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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