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PRODUCT DETAIL

Luxturna

Code 0462D
MA number EU/1/18/1331/001
Product Form: con sol 1x0,5 ml + 2x1,7 ml solv. (liek.inj. COC)
MA Status: E - Valid centralised marketing authorisation
Type of procedure: EU Orphan
Therapeutic Class: 64 - OPHTHALMOLOGICA
ATC:
S SENSORY ORGANS
S01 OPHTHALMOLOGICALS
S01X OTHER OPHTHALMOLOGICALS
S01XA Other ophthalmologicals
S01XA27 Voretigene neparvovec
Shelf life: 36
Prescription Status: Medicinal product subject to restricted medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 22.11.2018
Validity: 05.12.2028
SmPC + PL: European Medicines Agency's database
Dokument: Luxturna_karta pacienta_vacsi format.pdf  
Dokument: Luxturna_karta pacienta_mensi format.pdf  
Dokument: Luxturna_pisomna informacia pre pouzivatela_vacsi format.pdf  
Dokument: Luxturna_karta pacienta_audio.mp3  
Safety feature Yes
Data update: 18.08.2023
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