Overview

The marketing authorisation for Skysona has been withdrawn at the request of the marketing-authorisation holder.

Skysona : EPAR - Medicine overview

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română (RO) (749.78 KB - PDF)
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slovenščina (SL) (787.88 KB - PDF)
Suomi (FI) (714.38 KB - PDF)
svenska (SV) (716.09 KB - PDF)

Skysona : EPAR - Risk-management-plan summary

Product information

Skysona : EPAR - Product information

български (BG) (2.6 MB - PDF)
español (ES) (1.42 MB - PDF)
čeština (CS) (2.36 MB - PDF)
dansk (DA) (1.39 MB - PDF)
Deutsch (DE) (1.59 MB - PDF)
eesti keel (ET) (1.36 MB - PDF)
ελληνικά (EL) (2.63 MB - PDF)
français (FR) (1.52 MB - PDF)
hrvatski (HR) (1.44 MB - PDF)
íslenska (IS) (1.41 MB - PDF)
italiano (IT) (1.52 MB - PDF)
latviešu valoda (LV) (2.3 MB - PDF)
lietuvių kalba (LT) (1.64 MB - PDF)
magyar (HU) (2.17 MB - PDF)
Malti (MT) (2.29 MB - PDF)
Nederlands (NL) (1.56 MB - PDF)
norsk (NO) (1.38 MB - PDF)
polski (PL) (2.35 MB - PDF)
português (PT) (1.41 MB - PDF)
română (RO) (1.54 MB - PDF)
slovenčina (SK) (2.22 MB - PDF)
slovenščina (SL) (2.19 MB - PDF)
Suomi (FI) (1.49 MB - PDF)
svenska (SV) (1.41 MB - PDF)

18/11/2021

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This medicine’s product information is available in all official EU languages.
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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).

Skysona : EPAR - All authorised presentations

български (BG) (686.79 KB - PDF)
español (ES) (658.86 KB - PDF)
čeština (CS) (677.6 KB - PDF)
dansk (DA) (665.26 KB - PDF)
Deutsch (DE) (661.44 KB - PDF)
eesti keel (ET) (657.16 KB - PDF)
ελληνικά (EL) (683.93 KB - PDF)
français (FR) (659.43 KB - PDF)
hrvatski (HR) (659.52 KB - PDF)
íslenska (IS) (660.93 KB - PDF)
italiano (IT) (657.56 KB - PDF)
latviešu valoda (LV) (677.33 KB - PDF)
lietuvių kalba (LT) (661.7 KB - PDF)
magyar (HU) (677.38 KB - PDF)
Malti (MT) (679.82 KB - PDF)
Nederlands (NL) (657.82 KB - PDF)
norsk (NO) (660.61 KB - PDF)
polski (PL) (678.57 KB - PDF)
português (PT) (659.12 KB - PDF)
română (RO) (660.43 KB - PDF)
slovenčina (SK) (677.66 KB - PDF)
slovenščina (SL) (675.2 KB - PDF)
Suomi (FI) (655.9 KB - PDF)
svenska (SV) (659.33 KB - PDF)

Product details

Name of medicine
Skysona
Active substance
elivaldogene autotemcel
International non-proprietary name (INN) or common name
elivaldogene autotemcel
Therapeutic area (MeSH)
Adrenoleukodystrophy
Anatomical therapeutic chemical (ATC) code
N07

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.

Authorisation details

EMA product number
EMEA/H/C/003690
Marketing authorisation holder
bluebird bio (Netherlands) B.V.

Stadsplateau 7
3521 AZ Utrecht
The Netherlands

Opinion adopted
20/05/2021
Marketing authorisation issued
16/07/2021

Assessment history

Skysona : Orphan maintenance assessment report (initial authorisation)

Skysona : EPAR - Public assessment report

CHMP summary of positive opinion for Skysona

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