EU/3/12/958: Orphan designation for the diagnosis of positive folate-receptor status in ovarian cancer

N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine / folic acid


Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in September 2012 on request of the sponsor.

On 9 February 2012, orphan designation (EU/3/12/958) was granted by the European Commission to Endocyte Europe B.V., the Netherlands, for N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine and folic acid for the diagnosis of positive folate receptor status in ovarian cancer.

Key facts

Active substance
  • N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine
  • folic acid
Intended use
Diagnosis of positive folate-receptor status in ovarian cancer
Orphan designation status
EU designation number
Date of designation
Endocyte Europe B.V.
Prins Bernhardplein 200
1097 JB Amsterdam
The Netherlands
Telephone: +31 20 521 4777
Telefax: +31 20 521 4821

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

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.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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