This brand name is authorized in United States
The drug ELEVIDYS contains one active pharmaceutical ingredient (API):
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1
Delandistrogene moxeparvovec
UNII 2P6QV2ZE52 - DELANDISTROGENE MOXEPARVOVEC
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Delandistrogene moxeparvovec is the recombinant gene therapy product that is comprised of a non-replicating, recombinant, adeno-associated virus (AAV) serotype rh74 (AAVrh74) capsid and a ssDNA expression cassette flanked by inverted terminal repeats (ITRs) derived from AAV2. The cassette contains: 1) an MHCK7 gene regulatory component comprising a creatine kinase 7 promoter and an α-myosin heavy chain enhancer, and 2) the DNA transgene encoding the engineered delandistrogene moxeparvovec micro-dystrophin protein. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| ELEVIDYS Suspension for solution for infusion | FDA, National Drug Code (US) | MPI, US: SPL/PLR |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| M09AX15 | M Musculo-skeletal system → M09 Other drugs for disorders of the musculo-skeletal system → M09A Other drugs for disorders of the musculo-skeletal system → M09AX Other drugs for disorders of the musculo-skeletal system | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: US | FDA, National Drug Code | Identifier(s): 60923-501, 60923-502, 60923-504, 60923-505, 60923-506, 60923-507, 60923-508, 60923-509, 60923-510, 60923-511, 60923-512, 60923-513, 60923-514, 60923-515, 60923-516, 60923-517, 60923-518, 60923-519, 60923-520, 60923-521, 60923-522, 60923-523, 60923-524, 60923-525, 60923-526, 60923-527, 60923-528, 60923-529, 60923-530, 60923-531, 60923-532, 60923-533, 60923-534, 60923-535, 60923-536, 60923-537, 60923-538, 60923-539, 60923-540, 60923-541, 60923-542, 60923-543, 60923-544, 60923-545, 60923-546, 60923-547, 60923-548, 60923-549, 60923-550, 60923-551, 60923-552, 60923-553, 60923-554, 60923-555, 60923-556, 60923-557, 60923-559, 60923-560, 60923-561, 60923-562 |
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