COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di litio teriflunomide, «Teriflunomide Zentiva». (24A00222)
Estratto determina AAM/PPA n. 18/2024 del 12 gennaio 2024
E' autorizzata la variazione di tipo IB - B.II.e.5.a.2 con la conseguente immissione in commercio del medicinale TERIFLUNOMIDE ZENTIVA nella confezione di seguito indicata.
Confezione:
14 mg compresse rivestite con film
14 compresse in blister OPA- AL-PVC/AL - A.I.C. n. 050449038 - base 32 - 1J3LNG.
Forma farmaceutica: compresse rivestite con film.
Principio attivo: teriflunomide.
Codice pratica: C1B/2023/2194.
Codice di procedura europea: IS/H/0469/001/IB/002.
Titolare A.I.C.: Zentiva Italia S.r.l. con sede legale e domicilio fiscale in via P. Paleocapa n. 7, 20121 Milano, codice fiscale 11388870153.
Classificazione ai fini della rimborsabilita'
Per la nuova confezione sopracitata 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 nuova confezione sopracitata e' adottata la seguente classificazione ai fini della fornitura: RR - medicinale soggetto a prescrizione medica.
Stampati
La confezione del medicinale deve essere posta in commercio con gli stampati, cosi' come precedentemente autorizzati da questa amministrazione, con le sole modifiche necessarie per l'adeguamento alla presente determina.
In ottemperanza all'art. 80, commi...
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