Pharmaceuticals - Community Register


List of refusals for human medicinal products


Product name: Vynfinit
Active substance: vintafolide
Indication: Vynfinit in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of adult patients with platinum resistant ovarian cancer (PROC) who express the folate receptor (FR) on all target lesions. Folate receptor status should be assessed by a diagnostic medicinal product approved for the selection of adult patients for treatment with vintafolide, using single photon emission computed tomography (SPECT) imaging, in combination with Computed Tomography (CT) or Magnetic Resonance Imaging (MRI).
Marketing Authorisation Holder: Endocyte Europe B.V.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
7/08/2014 Centralised - Refusal of marketing authorisation EMEA/H/C/2571 (2014)5762 of 5/08/2014