EU/3/18/2112

About

On 14 December 2018, orphan designation (EU/3/18/2112) was granted by the European Commission to Merck Europe B.V., the Netherlands, for bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1 (also known as M7824) for the treatment of biliary tract cancer.

Key facts

Active substance
Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1
Disease / condition
Treatment of biliary tract cancer
Date of first decision
14/12/2018
Outcome
Positive
EU designation number
EU/3/18/2112

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

Merck Europe B.V.
Gustav Mahlerplein 102
lto Toren
1082 MA Amsterdam
The Netherlands
Tel. +31 2065 80548
E-mail: service@merckgroup.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;

How useful was this page?

Add your rating