BYLVAY

This brand name is authorized in Austria, Croatia, Estonia, France, Ireland, Israel, Italy, Lithuania, Poland, Romania, Spain.

Active ingredients

The drug BYLVAY contains one active pharmaceutical ingredient (API):

1	Odevixibat UNII Q76KP2H4XW - ODEVIXIBAT SESQUIHYDRATE
	Odevixibat is a reversible, potent, selective inhibitor of the ileal bile acid transporter (IBAT). Odevixibat acts locally in the distal ileum to decrease the reuptake of bile acids and increase the clearance of bile acids through the colon, reducing the concentration of bile acids in the serum. The extent of reduction of serum bile acids does not correlate with systemic PK.
	Read more about Odevixibat

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
BYLVAY Hard capsule	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
A05AX05		A Alimentary tract and metabolism → A05 Bile and liver therapy → A05A Bile therapy → A05AX Other drugs for bile therapy
Discover more medicines within A05AX05

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
EE	Ravimiamet	1858608, 1858619, 1858620, 1858631
ES	Centro de información online de medicamentos de la AEMPS	1211566001, 1211566002, 1211566003, 1211566004
FR	Base de données publique des médicaments	61197904, 62983550, 64376734, 68818769
IL	מִשְׂרַד הַבְּרִיאוּת	9196, 9197, 9198, 9199
IT	Agenzia del Farmaco	049571019, 049571021, 049571045
LT	Valstybinė vaistų kontrolės tarnyba	1093043, 1093044, 1093045, 1093046
PL	Rejestru Produktów Leczniczych	100457061, 100457106, 100457113, 100457120
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W68642001, W68643001, W68644001