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Bylvay▼ (odevixibat) paediatric indication leaflet

Progressive Familial Intrahepatic Cholestasis (PFIC) File
12 pages

This Bylvay paediatric leaflet provides: 

✓ An overview of Bylvay’s mode of action 

✓ Outcomes from the first global phase 3 trials in progressive familial intrahepatic cholestasis (PFIC) 

✓ Bylvay dosing and tolerability

BYL-UK-000415 | July 2025

Bylvay<span class='triangle'>▼</span> (odevixibat) paediatric indication leaflet
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▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. Reporting of side effects. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in Google Play or Apple App Store. Side effects should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone 01753 627777. By reporting side effects, you can help provide more information on the safety of this medicine.