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Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in September 2012 on request of the sponsor.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.
Diagnosis of positive folate-receptor status in ovarian cancer
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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
EU/3/12/958: Public summary of opinion on orphan designation: 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 (PDF/166.98 KB)
First published: 24/02/2012
Last updated: 12/11/2012
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: