COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Enalapril e Lercanidipina Krka», con conseguente modifica degli stampati. (20A07061)
Estratto determina AAM/PPA n. 775/2020 del 14 dicembre 2020
L'autorizzazione all'immissione in commercio e' rinnovata con validita' illimitata dalla data comune di rinnovo europeo (CRD) 28 luglio 2018 con conseguente modifica degli stampati
(HU/H/0334/002/R/001). E' autorizzata altresi', la variazione HU/H/0334/002/IB/015 tipo IB C.I.3.z) Aggiornamento dei paragrafi 4.3, 4.4 e 4.5 del riassunto delle caratteristiche del prodotto e dei corrispettivi paragrafi di foglio illustrativo al fine di implementare le raccomandazioni del PRAC (EMA/PRAC/752056/2018) a seguito dello PSUSA (00000749/201802) e modifiche editoriali all'etichettatura, relativamente al medicinale:
ENALAPRIL E LERCANIDIPINA KRKA (A.I.C. n. 045043)
. Dosaggio/formafarmaceutica: «20 mg/10 mg compresse rivestite con film» (tutte le confezioni autorizzate).
Titolare A.I.C.: Krka D.D. Novo Mesto con sede legale in Smarjeska Cesta 6, 8501 Novo mesto, Slovenia.
Codice procedura europea:
HU/H/0334/002/R/001
HU/H/0334/002/IB/015.
Codice pratica:
FVRMC/2017/179
C1B/2019/143.
Stampati
Le modifiche devono essere apportate per il riassunto delle caratteristiche del prodotto dalla data di entrata in vigore della presente determina mentre per il foglio illustrativo ed etichettatura entro e non oltre sei mesi dalla medesima data.
In ottemperanza all'art. 80, commi 1 e 3, del decreto legislativo 24 aprile 2006, n. 219 e successive modificazioni ed integrazioni il foglio illustrativo e le etichette devono essere redatti in lingua italiana e, limitatamente ai medicinali in commercio nella Provincia di Bolzano, anche in lingua tedesca. Il titolare dell'A.I.C. che intende avvalersi dell'uso complementare di lingue estere, deve darne preventiva comunicazione all'AIFA e tenere a...
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