COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano, a base di anastrozolo, «Anastrozolo Pensa». (24A01898)
Estratto determina AAM/PPA n. 250/2024 del 5 aprile 2024
E' autorizzata la variazione di Tipo IB, B.II.e.5.a.2 che comporta l'immissione in commercio del medicinale ANASTROZOLO PENSA nella confezione di seguito indicata:
principio attivo: anastrozolo - A.I.C. n. 049569027 «1 mg compresse rivestite con film» 30 compresse in blister PVC-PVDC/AL
(codice base 32 1H8R83).
Codice pratica: C1B/2023/483
Numero procedura: PT/H/2613/001/IB/002
Titolare A.I.C.: Towa Pharmaceutical S.p.a. - codice fiscale n. 02652831203, con sede legale e domicilio fiscale in via Enrico Tazzoli n. 6 - 20154 - Milano - Italia.
Classificazione ai fini della rimborsabilita'
Per la confezione sopracitata e' adottata la seguente classificazione ai fini della rimborsabilita': «C».
Classificazione ai fini della fornitura
Per la confezione sopracitata e' adottata la seguente classificazione ai fini della fornitura: «RR» medicinali soggetti 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 determina, di cui al presente estratto.
In ottemperanza all'art. 80 commi 1 e 3 del decreto...
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