Basic Information
Bylvay
Regulatory Information
EMEA/H/C/004691
Authorised
July 16, 2021
May 20, 2021
9
July 26, 2024
Company Information
France
65 Quai Georges Gorse 92100 Boulogne-Billancourt
IPSEN PHARMA
Drug Classification
Orphan MedicineExceptional CircumstancesAccelerated Assessment
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).
Overview Summary
Bylvay is a medicine for treating patients from the age of 6 months with progressive familial intrahepatic cholestasis (PFIC), a rare type of liver disease in which bile acids build up in the liver. Bile acids are a component of bile, a fluid produced in the liver that helps to absorb fats from the gut. Bylvay contains the active substance odevixibat.