Medicine guide
Skysona
·
- Prescription status not stated
- Pain, sleep, mood, epilepsy and the brain
- Active substance
- Elivaldogene autotemcel
- Made by
- bluebird bio (Netherlands) B.V.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- Treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an ABCD1 genetic mutation, and for whom a human leukocyte antigen (HLA) matched sibling haematopoietic stem cell donor is not available.
From the official label · 2026-09-30 · European Medicines Agency
Details
| Made by | bluebird bio (Netherlands) B.V. |
|---|---|
| Active substance | Elivaldogene autotemcel |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Classification | N07 · Pain, sleep, mood, epilepsy and the brain |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2021-07-16 |
| Last updated by the regulator | 2022-04-04 |
| EMA product number | EMEA/H/C/003690 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).