EU/3/15/1500

About

This medicine is now known as bulevirtide.

On 19 June 2015, orphan designation (EU/3/15/1500) was granted by the European Commission to MYR GmbH, Germany, for synthetic 47-amino-acid N-myristoylated lipopeptide, derived from the preS region of hepatitis B virus for the treatment of hepatitis delta virus infection.

The sponsor’s address was updated in September 2019.

Synthetic 47-amino-acid N-myristoylated lipopeptide, derived from the preS region of hepatitis B virus has been authorised in the EU as Hepcludex since 31 July 2020. 

Key facts

Active substance
"Synthetic 47-amino-acid N-myristoylated lipopeptide, derived from the preS region of hepatitis B virus (bulevirtide)
Medicine name
Hepcludex
Disease / condition
Treatment of hepatitis delta virus infection
Date of first decision
19/06/2015
Outcome
Positive
EU designation number
EU/3/15/1500

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Hepcludex at the time of marketing authorisation, and confirmed that the orphan designation should be maintained. 

More information is available in the PDF iconorphan medicine assessment report .

Sponsor's contact details

MYR GmbH
Hessenring 89
Bad Homburg
Hesse 61348
Germany 
Tel. +49 176 5577 0748
E-mail: sarah.buechner@myr-pharma.com 

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

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