Pharmaceuticals - Community Register

  

List of refusals for human medicinal products

Neocepri

Product name: Neocepri
INN: FOLIC ACID
Indication: This medicinal product is for diagnostic use only.
Neocepri is administered prior to 99mTc-etarfolatide, a folate receptor (FR) targeted radiodiagnostic imaging agent for use in ovarian cancer. Neocepri is indicated for the enhancement of 99mTc-etarfolatide single photon emission computed tomography (SPECT) image quality.
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
07/08/2014 Centralised - Refusal of marketing authorisation EMEA/H/C/2773 (2014)5761 of 05/08/2014