COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Rifadin». (15A03769)
Estratto determina V&A n. 841/2015 del 29 aprile 2015 Autorizzazione della proroga scorte relativamente al medicinale: "RIFADIN" Confezioni: AIC n. 021110034 - "300 mg capsule rigide" 8 capsule AIC n. 021110200 - "150 mg capsule rigide" 8 capsule Titolare AIC: Sanofi S.p.a. con sede legale e domicilio fiscale in Viale Luigi Bodio, 37/B, 20158 - Milano (MI) Italia - Codice Fiscale 00832400154. E' autorizzato, a decorrere dalla data del termine del periodo precedentemente autorizzato per lo smaltimento delle scorte, il mantenimento delle confezioni gia' immesse in commercio per ulteriori 120 giorni, ai sensi di quanto previsto dall'art. 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 14/04/2014, 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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