EU/3/12/1043

About

On 10 September 2012, orphan designation (EU/3/12/1043) 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 to be used with folic acid for the diagnosis of positive folate-receptor status in ovarian cancer.

The sponsorship was transferred to Voisin Consulting S.A.R.L., France, in December 2016

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 to be used with folic acid
Medicine name
Folcepri
Disease / condition
Diagnosis of positive folate-receptor status in ovarian cancer
Date of first decision
10/09/2012
Outcome
Positive
EU designation number
EU/3/12/1043

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

Voisin Consulting S.A.R.L.
64 Avenue Pierre Grenier
92100 Boulogne-Billancourt
France
Tel. +33 1413 18300
E-mail: orphan@voisinconsulting.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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