EU/3/10/803

About

On 26 November 2010, orphan designation (EU/3/10/803) was granted by the European Commission to Ganymed Pharmaceuticals AG, Germany, for chimeric monoclonal antibody against claudin-18 splice variant 2 for the treatment of gastric cancer.

In May 2017 sponsor, Ganymed Pharmaceuticals AG changed name to Ganymed Pharmaceuticals AG GmbH.

The sponsorship was transferred to Astellas Pharma Europe B.V., The Netherlands, in March 2018.

Key facts

Active substance
Chimeric monoclonal antibody against claudin-18 splice variant 2
Disease / condition
treatment of gastric cancer
Date of decision
26/11/2010
Outcome
Positive
Orphan decision number
EU/3/10/803

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

Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands
Tel. +31(0)71 545 5878
E-mail: contact@nl.astellas.com

Patients' organisations

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

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

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