USA - engelsk - NLM (National Library of Medicine)

spark therapeutics, inc. - voretigene neparvovec (unii: 2spi046ikd) (voretigene neparvovec - unii:2spi046ikd) - voretigene neparvovec 0.05 mg - luxturna (voretigene neparvovec-rzyl) is an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic rpe65 mutation-associated retinal dystrophy. patients must have viable retinal cells as determined by the treating physician(s). none. risk summary adequate and well-controlled studies with luxturna have not been conducted in pregnant women. animal reproductive studies have not been conducted with luxturna. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of luxturna in human milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for luxturna and any potential adverse effects on the breastfed infant from luxturna. no nonclinical or clinica

Den europeiske union - portugisisk - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna é indicado para o tratamento de doentes adultos e pediátricos com perda de visão devido a herdadas de retina, distrofia causado por confirmou comportamento bialélico rpe65 mutações e que têm bastante viável células da retina.

Den europeiske union - nederlandsk - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna is geïndiceerd voor de behandeling van volwassen en pediatrische patiënten met verlies van het gezichtsvermogen door erfelijke retinale dystrofie veroorzaakt door bevestigd biallelic rpe65 mutaties, en die over voldoende levensvatbaar retinale cellen.

Den europeiske union - maltesisk - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna huwa indikat għall-kura ta ' pazjenti adulti u pedjatriċi b'telf tal-vista minħabba ereditarju tar-retina distrofija kkawżati minn kkonfermat biallelic rpe65 mutazzjonijiet u li jkollu biżżejjed vijabbli tar-retina-ċelluli.

Den europeiske union - italiensk - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna è indicato per il trattamento di pazienti adulti e pediatrici con perdita della vista a causa della distrofia retinica ereditaria causata da confermato biallelica rpe65 mutazioni e che hanno una sufficiente vitali delle cellule della retina.

Den europeiske union - rumensk - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna este indicat pentru tratamentul pacienților adulți și pacienți copii și adolescenți cu pierderea vederii din cauza moștenit distrofie retinei cauzate de confirmat biallelic rpe65 mutații și care au suficient de viabile celulele retinei.

Den europeiske union - gresk - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna ενδείκνυται για τη θεραπεία ενηλίκων και παιδιατρικών ασθενών με απώλεια όρασης λόγω κληρονομική δυστροφία του αμφιβληστροειδούς που προκαλείται από την επιβεβαίωσε biallelic rpe65 μεταλλάξεις και που έχουν επαρκή και βιώσιμα κύτταρα του αμφιβληστροειδούς.

Den europeiske union - fransk - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna est indiqué pour le traitement de patients adultes et pédiatriques avec une perte de vision due à la dystrophie rétinienne héréditaire causée par confirmé biallélique rpe65 mutations et qui ont suffisamment viable cellules de la rétine.

Den europeiske union - bulgarsk - EMA (European Medicines Agency)

novartis europharm limited  - voretigene neparvovec - leber congenital amaurosis; retinitis pigmentosa - other ophthalmologicals - luxturna е показан за лечение и педиатрични възрастни пациенти със загуба на зрението поради наследство дистрофия на ретината, причинени от потвърди rpe65 биаллельных мутации, които са достатъчно жизнеспособни клетки на ретината.

Israel - engelsk - Ministry of Health

novartis israel ltd - voretigene neparvovec - concentrate and solvent for solution for injection - voretigene neparvovec 5x10^12 vector genomes/ml - luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic rpe65 mutations and who have sufficient viable retinal cells.