26.07.2017

Neovii completes marketing authorisation withdrawal of Removab® in the European Union

 

Neovii completes marketing authorisation withdrawal of Removab® in the European Union

At the request of Neovii Biotech GmbH, the European Commission withdrew the marketing authorisation for Removab® (catumaxomab) in the European Union (EU).
 

Removab® was granted marketing authorisation in the EU on 20 April 2009 for treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
 

Since 2014, Removab® could not be marketed due to the insolvency of the manufacturer of the drug substance. Therefore, Neovii Biotech GmbH notified the European Commission of its decision to permanently discontinue the marketing of the product.