Kayfanda (odevixibat)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- odevixibat
- Company
- Ipsen Pharma
- Status
- Authorised
- Therapeutic area
- Pruritus; Alagille Syndrome
- CHMP opinion
- Thu 25 Jul 2024
- EU approval
- Thu 19 Sep 2024
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/006462
- ATC
- A05AX05
- Official record
- www.ema.europa.eu
Indication
Kayfanda is indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older (see sections 4.4 and 5.1).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Bylvay Authorised · Ipsen Pharma
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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.