COMUNICATO - Autorizzazione della proroga scorte relativamente al medicinale per uso umano «Topotecan Kabi». (14A06739)
Estratto determinazione V &
A n. 1609/2014 del 28 luglio 2014 Specialita' medicinale: «TOPOTECAN KABI». Confezioni: «4 mg polvere per concentrato per soluzione per infusione» 1 flaconcino in vetro - A.I.C. n. 041234016;
4 mg polvere per concentrato per soluzione per infusione
5 flaconcini in vetro - A.I.C. n. 041234028. Titolare AIC: Fresenius Kabi Oncology PLC con sede legale e domicilio in Lion Court, Farnham Road, GU35 ONF Bordon Hampshire - Gran Bretagna. E' autorizzato, a decorrere dalla data di entrata in vigore della determinazione, di cui al presente estratto, il mantenimento in commercio delle confezioni gia' prodotte, fino alla data di scadenza del medicinale indicata in etichetta, previa 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 determinazione del Direttore Generale dell'AIFA concernente «Criteri per l'applicazione delle disposizioni relative allo smaltimento delle scorte dei medicinali» n. 371 del 14 aprile 2014, adottata, in attuazione dell'art. 37 del decreto legislativo n. 219/2006, cosi' come modificato dall'art. 44, comma 4-quinquies del decreto-legge 21 giugno 2013, n. 69, recante: «Disposizioni...
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