Rilonacept Regeneron (previously Arcalyst) (rilonacept)
Exceptional circumstances
- Region
- 🇪🇺 EU
- Active substance
- rilonacept
- Company
- Regeneron UK Limited
- Status
- Withdrawn
- Therapeutic area
- Cryopyrin-Associated Periodic Syndromes
- EU approval
- Fri 23 Oct 2009
- Designations
- Exceptional circumstances
- Application
- EMEA/H/C/001047
- ATC
- L04AC08
- Official record
- www.ema.europa.eu
Indication
Rilonacept Regeneron is indicated for the treatment of cryopyrin-associated periodic syndromes (CAPS) with severe symptoms, including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS), in adults and children aged 12 years and older.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Rilonacept FGK Representative Service GmbH Application withdrawn · Rilonacept FGK Representative Service GmbH
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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.