Hepcludex
bulevirtide
Table of contents
Overview
Hepcludex is an antiviral medicine used to treat chronic (long-term) hepatitis delta virus (HDV) infection in adults with compensated liver disease (when the liver is damaged but is still able to work), when the presence of viral RNA (genetic material) has been confirmed by blood tests.
HDV is an 'incomplete' virus, because it cannot replicate in cells without the help of another virus, the hepatitis B virus. Because of this, patients infected with the virus always also have hepatitis B.
HDV infection is rare, and Hepcludex was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 June 2015. Further information on the orphan designation can be found on the EMA website.
Hepcludex contains the active substance bulevirtide.
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List item
Hepcludex : EPAR - Medicine overview (PDF/111.72 KB)
First published: 12/08/2020
Last updated: 25/07/2023
EMA/312782/2020 -
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Hepcludex : EPAR - Risk-management-plan summary (PDF/182.19 KB)
First published: 12/08/2020
Last updated: 25/07/2023
Authorisation details
Product details | |
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Name |
Hepcludex
|
Agency product number |
EMEA/H/C/004854
|
Active substance |
Bulevirtide acetate
|
International non-proprietary name (INN) or common name |
bulevirtide
|
Therapeutic area (MeSH) |
Hepatitis D, Chronic
|
Anatomical therapeutic chemical (ATC) code |
J05A
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Orphan |
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 | |
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Marketing-authorisation holder |
Gilead Sciences Ireland UC
|
Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
31/07/2020
|
Contact address |
Carrigtohill |
Product information
18/07/2023 Hepcludex - EMEA/H/C/004854 - II/0019
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
Antivirals for systemic use
Therapeutic indication
Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease.