Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Luxturna 5 × 1012 vector genomes/mL concentrate and solvent for solution for injection.
| Pharmaceutical Form |
|---|
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Concentrate and solvent for solution for injection. Following thaw from their frozen state, both the concentrate and the solvent are clear, colourless liquids with a pH of 7.3. |
Voretigene neparvovec is a gene transfer vector that employs an adeno-associated viral vector serotype 2 (AAV2) capsid as a delivery vehicle for the human retinal pigment epithelium 65 kDa protein (hRPE65) cDNA to the retina. Voretigene neparvovec is derived from naturally occurring AAV using recombinant DNA techniques.
Each mL of concentrate contains 5 × 1012 vector genomes (vg).
Each single-dose 2 mL vial of Luxturna contains 0.5 extractable mL of concentrate which requires a 1:10 dilution prior to administration, see section 6.6.
After dilution each dose of Luxturna contains 1.5 × 1011 vg in a deliverable volume of 0.3 mL.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Voretigene neparvovec |
Voretigene neparvovec results to transduction of retinal pigment epithelial cells with a cDNA encoding normal human RPE65 protein (gene augmentation therapy), providing the potential to restore the visual cycle in patients with vision loss due to inherited retinal dystrophy. |
| List of Excipients |
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Concentrate: Sodium chloride Solvent: Sodium chloride |
0.5 mL extractable volume of concentrate in 2 mL cyclic olefin polymer vial with a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal.
1.7 mL extractable volume of solvent in a 2 mL cyclic olefin polymer vial with a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal.
Each foil pouch includes a carton containing 1 vial of concentrate and 2 vials of solvent.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/18/1331/001
22 November 2018
| Drug | Countries | |
|---|---|---|
| LUXTURNA | Austria, Brazil, Estonia, Spain, France, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, United Kingdom |
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