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Skyclarys
Authorised
Human
Orphan medicine
Details
EMA number
EMEA/H/C/006084
ATC code
N07XX25
Authorisation
9 February 2024
Revision
8
EMA page
Therapeutic indication
The treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
MeSH:
Friedreich Ataxia
Group:
Other nervous system drugs
Special characteristics
Additional monitoring
Active substances
omaveloxolone
Marketing Authorisation Holder
Biogen Netherlands B.V.
MAH
Timeline
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EMA
Skyclarys authorised
9 Feb 2024
authorised
regulatory
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