Detailed SMPC and OD register data for: Skyclarys 50 mg hard capsules
Data as extracted from Orphan Designation Register
Product (OD)
Skyclarys 50 mg hard capsules
PL number (OD)
PLGB 22407/0033
OD Designation ID (OD)
OD1
Active substance (OD)
OMAVELOXOLONE
Data as extracted from SMPC. (PS: More information at bottom of the page)
Product (SMPC)
PL Number (SMPC)
Composition/ Active Substance (SMPC)
Dose form (SMPC)
Marketing Authorisation holder details (SMPC)
AI match to EMA Substance Dictionary
We analysed the SMPC composition text and searched for the closest equivalent in EMA's published substance dictionary. The suggested match and supporting details are shown below.
SMPC composition / active substance
Matched EMA substance
EMA SMS ID
Confidence
Higher confidence means the match is more likely to be correct.
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Further information for:
Select a section below to read the detailed content extracted from the SMPC / Orphan Designation register.
OD Indication (OD)
treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
Full Designation Number(OD)
PLGB 22407/0033/OD1
Orphan Condition(OD)
Friedreich’s ataxia
All Indications (SMPC)
All Contraindications (SMPC)
Warnings/Precautions (SMPC)
Interactions (SMPC)
Pregnancy/Lactation (SMPC)
Driving/Machines (SMPC)
Undesirable effects (SMPC)
Overdose (SMPC)
Shelf life (SMPC)
Storage (SMPC)
Container description (SMPC)
Handling/Disposal (SMPC)
SMPC_URL