COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Prohance» (21A02568)
Estratto determina AAM/PPA n. 317/2021 del 20 aprile 2021
Codici pratica: VN2/2020/6 - N1B/2020/2116.
Si autorizzano le variazioni di tipo II - B.II.e.5.c «Modifica delle dimensioni dell'imballaggio del prodotto finito - Modifica del peso/volume di riempimento di medicinali sterili multidose (o a dose unica, utilizzo parziale) per uso parenterale compresi medicinali biologici/immunologici» e di tipo IB, B.II.e.4.c «Modifica della forma o delle dimensioni del contenitore o della chiusura
(confezionamento primario). Medicinali sterili.», per l'immissione in commercio del medicinale PROHANCE (A.I.C. n. 029055), anche nella forma farmaceutica e confezione di seguito indicata:
confezione: «279,3 mg/ml soluzione per infusione»1 flacone da 100 ml
A.I.C.: n. 029055136 (base 10) 0VQQ50 (base 32)
forma farmaceutica: soluzione per infusione.
principio attivo: gadoteridolo.
Titolare A.I.C.: Bracco Imaging Italia S.r.l. (codice fiscale n. 05501420961).
Classificazione ai fini della rimborsabilita'
Per la confezione sopracitata e' adottata la seguente classificazione ai fini della rimborsabilita': «C(nn)», classe non negoziata.
Classificazione ai fini della fornitura
Per la confezione sopracitata e' adottata la seguente classificazione ai fini della fornitura: «OSP».
Stampati
La confezione del medicinale deve essere posta in commercio con gli stampati, cosi' come precedentemente autorizzati da questa Amministrazione, con le sole...
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