COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Netildex» (20A07107)
Estratto determina AAM/PPA n. 774/2020 del 14 dicembre 2020
Codice pratica: N1B/2020/1142.
Si autorizza la variazione, B.II.e.5.a.2 per l'immissione in commercio del medicinale NETILDEX anche nella forma farmaceutica e confezione di seguito indicata:
confezione: «3 mg/ml/1mg/ml collirio, soluzione in contenitore monodose», 30 contenitori in LDPE da 0,3 ml - A.I.C. n. 036452062
(base 10) 12SFQY (base 32).
Forma farmaceutica: collirio, soluzione.
Principio attivo: netilmicina e desametasone.
La descrizione delle confezioni gia' autorizzate (011, 023, 035) viene aggiornata secondo standard term da:
011 - 3mg/ml/1 mg/ml collirio, soluzione da 5 ml
023 - 3mg/ml/1 mg/ml collirio, soluzione 15 contenitori monodose
035 - 3mg/ml/1 mg/ml collirio, soluzione 20 contenitori monodose
a
011 - 3mg/ml/1 mg/ml collirio, soluzione in flacone LDPE da 5 ml
023 - 3mg/ml/1 mg/ml collirio, soluzione in contenitore monodose, 15 contenitori LDPE da 0,3 ml
035 - 3mg/ml/1 mg/ml collirio, soluzione in contenitore monodose, 20 contenitori LDPE da 0,3 ml.
Codice pratica: N1B/2020/1142.
Titolare A.I.C.: SIFI S.p.a. (codice fiscale 00122890874).
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: «RR», ricetta ripetibile
Stampati
La confezione del medicinale deve essere posta in commercio con gli stampati, cosi' come precedentemente autorizzati da questa...
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