EU/3/16/1657

About

This medicine is now known as derazantinib.

On 30 May 2016, orphan designation (EU/3/16/1657) was granted by the European Commission to Coté Orphan Consulting UK Limited, United Kingdom, for (R)-6-(2-fluorophenyl)-N-(3-(2-((2-methoxyethyl)amino)ethyl)phenyl)-5,6-dihydrobenzo[h]quinazolin-2-amine dihydrochloride for the treatment of biliary tract cancer.

The sponsorship was transferred to Basilea Pharmaceutica Deutschland GmbH, Germany, in May 2019.

Key facts

Active substance
(R)-6-(2-fluorophenyl)-N-(3-(2-((2-methoxyethyl)amino)ethyl)phenyl)-5,6-dihydrobenzo[h]quinazolin-2-amine dihydrochloride (derazantinib)
Disease / condition
Treatment of biliary tract cancer
Date of first decision
30/05/2016
Outcome
Positive
EU designation number
EU/3/16/1657

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

Basilea Pharmaceutica Deutschland GmbH
Marie-Curie-Strasse 8
79539 Loerrach
Germany
Tel. +49 7621 1639475
E-mail: medical.lnformation@basilea.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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