Hepcludex

RSS

bulevirtide

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

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. For further information on the orphan designation, see EU/3/15/1500.

Hepcludex contains the active substance bulevirtide.

This EPAR was last updated on 07/10/2020

Authorisation details

Product details
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 monitoringAdditional 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.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

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
MYR GmbH
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
31/07/2020
Contact address

Hessenring 89
61348 Bad Homburg
Germany

Product information

05/10/2020 Hepcludex - EMEA/H/C/004854 - IB/0001

Contents

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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.

Assessment history

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