COMUNICATO - Autorizzazione all'immissione in commercio del medicinale per uso umano «Octagam». (17A06369)
Estratto determina PPA/AAM n. 856 del 4 settembre 2017 Codice pratica: VC2/2016/661. Descrizione del medicinale e attribuzione n. A.I.C. E' autorizzata, in aggiunta alle confezioni gia' autorizzate, l'immissione in commercio del medicinale OCTAGAM, nelle forme e confezioni di seguito indicate: confezione «50 mg/ml soluzione per infusione» 1 flaconcino in vetro da 20 ml - A.I.C. n. 035143054 (Base 10) 11JHDG (Base 32);
confezione «50 mg/ml soluzione per infusione» 2 flaconi in vetro da 200 ml - A.I.C. n. 035143066 (Base 10) 11JHDU (Base 32);
confezione «50 mg/ml soluzione per infusione» 3 flaconi in vetro da 200 ml - A.I.C. n. 035143078 (Base 10) 11JHF6 (Base 32). Forma farmaceutica: soluzione per infusione. Principio attivo: immunoglobulina umana normale. Si modifica, inoltre, la denominazione delle confezioni gia' autorizzate (035143015, 035143027, 035143039, 035143041), nella parte relativa alla forma farmaceutica, per adeguarsi agli standard terms: da: «soluzione per infusione endovenosa»;
a: «soluzione per infusione». Titolare A.I.C.: Octapharma LTD, con sede legale e domicilio fiscale in Manchester, the Zenith Building, 26 Spring Gardens, Cap M2 1AB, Regno Unito (UK). Classificazione ai fini della rimborsabilita' Per le confezioni sopracitate 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 le confezioni sopracitate e' adottata la seguente classificazione ai fini della fornitura: OSP - medicinali utilizzabili...
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