COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Fluad». (17A05392)
Estratto determina AAM/PPA n. 741 del 12 luglio 2017 E' autorizzata l'immissione in commercio del medicinale FLUAD anche nelle forme e confezioni di seguito indicate: Confezioni: «sospensione iniettabile per uso intramuscolare» 1 siringa preriempita da 0,5 ml senza ago con sistema luer lock - A.I.C. n. 031840073 (base 10) 0YCPU9 (base 32);
sospensione iniettabile per uso intramuscolare
10 siringhe preriempite da 0,5 ml senza ago con sistema luer lock - A.I.C. n. 031840085 (base 10) 0YCPUP (base 32). Forma farmaceutica sospensione iniettabile per uso intramuscolare. Principio attivo: vaccino influenzale inattivato, antigene di superficie, adiuvato con MF59C.1 Titolare A.I.C.: Seqirus S.r.l., con sede legale e domicilio fiscale in Siena (SI), via Fiorentina 1, cap 53100, codice fiscale n. 01391810528. Classificazione ai fini della rimborsabilita' Per tutte le confezioni di cui all'art. 1 e' adottata la seguente classificazione ai fini della rimborsabilita': apposita sezione della classe di cui all'art. 8, comma 10, lettera c) della legge 24 dicembre 1993, n. 537 e successive modificazioni, dedicata ai farmaci non ancora valutati ai fini della rimborsabilita', denominata classe C (nn). Classificazione ai fini della fornitura Per la confezione «sospensione iniettabile per uso intramuscolare» 1 siringa preriempita da 0,5 ml senza ago con sistema luer lock (A.I.C. n. 031840073) e' adottata la seguente classificazione ai fini della fornitura: RR medicinali soggetti a prescrizione medica. Per la confezione «sospensione iniettabile per uso intramuscolare» 10 siringhe preriempite da 0,5 ml senza ago con sistema luer lock (A.I.C. n. 031840085) e' adottata la seguente classificazione ai fini della fornitura: OSP medicinali utilizzabili esclusivamente in ambiente ospedaliero o in ambiente ad esso assimilabile. Le aggiunte confezioni, sopra riportate, prevedono la modifica del riassunto delle caratteristiche del...
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