COMUNICATO - Rinnovo dell'autorizzazione all'immissione in commercio, secondo procedura decentrata, del medicinale per uso umano «Travoprost Zentiva», con conseguente modifica stampati. (21A01998)
Estratto determina AAM/PPA n. 212/2021 del 18 marzo 2021
Rinnovo dell'autorizzazione all'immissione in commercio secondo procedura decentrata DK/H/2287/001/R/001 del medicinale TRAVOPROST ZENTIVA con conseguente modifica stampati.
L'autorizzazione all'immissione in commercio del
medicinale: «Travoprost Zentiva».
Confezioni:
045143017 - «40 microgrammi/ml collirio, soluzione» 1 flacone in LDPE
045143029 - «40 microgrammi/ml collirio, soluzione» 3 flaconi in LDPE.
Titolare A.I.C.: Zentiva Italia S.r.l. con sede legale e domicilio fiscale in viale Luigi Bodio, 37/B - 20158 - Milano
(Italia) - codice fiscale/partita IVA 11388870153.
Procedura: decentrata.
Codice procedura europea: DK/H/2287/001/R/001.
Codice pratica: FVRMC/2018/102,
e' rinnovata con validita' illimitata dalla data comune di rinnovo europeo (CRD) 17 settembre 2018, con conseguente modifica del riassunto delle caratteristiche del prodotto, del foglio illustrativo e dell'etichettatura.
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 e l'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 disposizione la traduzione giurata dei testi in lingua...
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