Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Itvisma 1.2 × 1014 vector genomes solution for injection.
| Pharmaceutical Form |
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Solution for injection. A clear to slightly opaque, colourless to faint white solution with a pH of 7.7 to 8.3 and osmolality of 390 to 430 mOsm/kg. |
Onasemnogene abeparvovec is a gene therapy medicinal product that expresses the human survival motor neuron (SMN) protein. It is a non-replicating recombinant adeno-associated virus serotype 9 (AAV9) based vector containing the cDNA of the human SMN gene under the control of the cytomegalovirus enhancer/chicken-β-actin-hybrid promoter.
Onasemnogene abeparvovec is produced in human embryonic kidney cells by recombinant DNA technology.
Each single-dose vial contains 1.2 × 1014 vector genomes (vg) of onasemnogene abeparvovec in 3 mL of solution. Onasemnogene abeparvovec intrathecal injection has a nominal concentration of 4 × 1013 vg/mL, and each vial contains an extractable volume of not less than 3 mL.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Onasemnogene abeparvovec is a gene therapy designed to introduce a functional copy of the survival motor neuron gene (SMN1) in the transduced cells to address the monogenic root cause of the disease. By providing an alternative source of SMN protein expression in motor neurons, it is expected to promote the survival and function of transduced motor neurons. |
| List of Excipients |
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Tromethamine |
Itvisma is supplied in a single-dose clear vial (5 mL cyclic olefin polymer) with stopper (20 mm chlorobutyl rubber) and seal (aluminium, flip-off) with a coloured cap (plastic). Each vial has a fill volume of 3 mL.
Each carton contains 1 vial.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/26/2038/001
| Drug | Countries | |
|---|---|---|
| ITVISMA | Austria, Lithuania, Romania |
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