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.

Key facts

Active substance
"Synthetic 47-amino-acid N-myristoylated lipopeptide, derived from the preS region of hepatitis B virus (bulevirtide)
Medicine name
-
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 reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

MYR GmbH
Hessenring 89
Bad Homburg
Hesse 61348
Germany 
Tel. +49 89 4442 9498
E-mail: alexandrov@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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