Skysona
elivaldogene autotemcel
Table of contents
Overview
The marketing authorisation for Skysona has been withdrawn at the request of the marketing-authorisation holder.
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List item
Skysona : EPAR - Medicine overview (PDF/719.27 KB)
First published: 27/07/2021
Last updated: 04/04/2022
EMA/413176/2021 -
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Skysona : EPAR - Risk-management-plan summary (PDF/758.42 KB)
First published: 27/07/2021
Last updated: 04/04/2022
Authorisation details
| Product details | |
|---|---|
| Name |
Skysona
|
| Agency product number |
EMEA/H/C/003690
|
| Active substance |
elivaldogene autotemcel
|
| International non-proprietary name (INN) or common name |
elivaldogene autotemcel
|
| Therapeutic area (MeSH) |
Adrenoleukodystrophy
|
| Anatomical therapeutic chemical (ATC) code |
N07
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
bluebird bio (Netherlands) B.V.
|
| Date of issue of marketing authorisation valid throughout the European Union |
16/07/2021
|
| Contact address |
Stadsplateau 7 |
Product information
18/11/2021 Skysona - EMEA/H/C/003690 -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Other nervous system drugs
Therapeutic indication
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.