Onasemnogen-Abeparvovec (1) – Zolgensma®
Spinal muscular atrophy (SMA)
Characteristics
| Start date | 01.07.2020 |
|---|---|
| Resolution | 03.12.2020 |
| INN | Onasemnogen-Abeparvovec |
| Brand name | Zolgensma® |
| Pharm. company |
Dossier: AveXis
New distributor: NOVARTIS Pharma GmbH |
| G-BA Procedure ID | D-549 |
| ATC code | M09AX09 Other drugs for disorders of the musculo-skeletal system (M09AX) |
| DDD | 1 U P |
| Therapeutic area | Nervous system diseases Spinal muscular atrophy (SMA) Orphan |
| Reason for procedure | not completed: suspended |
| Regulatory status | Conditional Approval ATMP |
Associated procedures
| Onasemnogen-Abeparvovec (2) | Zolgensma® | Novartis Gene Therapies EU Limited | 5q-associated spinal muscular atrophy (SMA) | 46–67 | 100% additional benefit not proven Orphan (turnover limit) | |
| Onasemnogen-Abeparvovec (1) | Zolgensma® | AveXis | Spinal muscular atrophy (SMA) | n.d. | suspended Orphan |
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