Overview
The marketing authorisation for Skysona has been withdrawn at the request of the marketing-authorisation holder.
Skysona : EPAR - Medicine overview
English (EN)
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italiano (IT)
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latviešu valoda (LV)
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português (PT)
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română (RO)
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slovenčina (SK)
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slovenščina (SL)
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Suomi (FI)
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svenska (SV)
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Skysona : EPAR - Risk-management-plan summary
English (EN)
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Product information
Skysona : EPAR - Product information
English (EN)
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български (BG)
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español (ES)
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čeština (CS)
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dansk (DA)
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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)
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íslenska (IS)
(1.41 MB - PDF)
italiano (IT)
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latviešu valoda (LV)
(2.3 MB - PDF)
lietuvių kalba (LT)
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magyar (HU)
(2.17 MB - PDF)
Malti (MT)
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Nederlands (NL)
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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
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).
Skysona : EPAR - All authorised presentations
English (EN)
(659.4 KB - PDF)View
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 drugsTherapeutic 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
This page was last updated on