Bylvay

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odevixibat

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 05/10/2022

Authorisation details

Product details
Name
Bylvay
Agency product number
EMEA/H/C/004691
Active substance
Odevixibat
International non-proprietary name (INN) or common name
odevixibat
Therapeutic area (MeSH)
Cholestasis, Intrahepatic
Anatomical therapeutic chemical (ATC) code
A05AX
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Exceptional circumstancesExceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Albireo
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
16/07/2021
Contact address

Arvid Wallgrens Backe 20
Gothenburg
SWEDEN

Product information

20/09/2022 Bylvay - EMEA/H/C/004691 - IB/0009/G

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Bile and liver therapy

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).

Assessment history

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