SKYSONA

This brand name is authorized in Estonia, France, Lithuania, Poland.

Active ingredients

The drug SKYSONA contains one active pharmaceutical ingredient (API):

1
UNII KUM75TD6SG - ELIVALDOGENE AUTOTEMCEL
 

Elivaldogene autotemcel is indicated for the treatment of early cerebral adrenoleukodystrophy in patients less than 18 years of age, with an ABCD1 genetic mutation. Elivaldogene autotemcel adds functional copies of the ABCD1 cDNA into patients' HSCs through transduction of autologous CD34+ cells with Lenti-D LVV. Following successful engraftment with genetically modified cells, the expression of ALDP is expected to be life-long.

 
Read more about Elivaldogene autotemcel

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 SKYSONA Dispersion for infusion MPI, EU: SmPC European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
N07 Other nervous system drugs N Nervous system
Discover more medicines within N07

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
EE Ravimiamet 1858596
FR Base de données publique des médicaments 65249832
LT Valstybinė vaistų kontrolės tarnyba 1093082
PL Rejestru Produktów Leczniczych 100456917

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