Skysona

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elivaldogene autotemcel

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Skysona has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 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 monitoringAdditional 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
3521 AZ Utrecht
The Netherlands

Product information

18/11/2021 Skysona - EMEA/H/C/003690 -

Product information documents contain:

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.

Assessment history

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