COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Aplactin» (20A01637)
Estratto determina AAM/PPA n. 169 del 3 marzo 2020 Variazione di tipo II: B.II.e.5.a.2) e conseguentemente di essere autorizzata a mettere in commercio il medicinale APLACTIN anche nelle forme e confezioni: «20 mg compresse» 28 compresse in blister PVC/PE/PVC/AL e «40 mg compresse» 28 compresse in blister PVC/PE/PVC/AL. Codice pratica: N1B/2019/1670. E' autorizzata l'immissione in commercio del medicinale APLACTIN, anche nelle forme e confezioni di seguito indicate: confezioni: «20 mg compresse» 28 compresse in blister PVC/PE/PVC/AL - A.I.C. n. 027786060 (in base 10) 0UHYUD (in base 32);
40 mg compresse
28 compresse in blister PVC/PE/PVC/AL - A.I.C. n. 027786072 (in base 10) 0UHYUS (in base 32). Forma farmaceutica: compresse. Principio attivo: pravastatina. Titolare A.I.C.: F.I.R.M.A. S.p.A. (codice fiscale 00394440481) con sede legale e domicilio fiscale in via di Scandicci, 37 - 50143 - Firenze (FI) Italia. Classificazione ai fini della rimborsabilita' Per le confezioni di cui all'art. 1 e' adottata la seguente classificazione ai fini della rimborsabilita': classe di 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 di cui all'art. 1 e' adottata la seguente classificazione ai fini della fornitura...
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