Riulvy (tegomil fumarate)
GenericAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- tegomil fumarate
- Company
- Neuraxpharm Pharmaceuticals S.L.
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis, Relapsing-Remitting
- CHMP opinion
- Thu 22 May 2025
- EU approval
- Mon 28 Jul 2025
- Designations
- Generic, Additional monitoring
- Application
- EMEA/H/C/006427
- ATC
- L04AX10
- Official record
- www.ema.europa.eu
Indication
Riulvy is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.