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AKTUALNOŚCI >> Statement of Mabion S.A.

Statement of Mabion S.A.

24.05.2016

Statement of Mabion S.A.

Today, Sandoz made public that it submitted an application to the European Medicines Agency (EMA) for marketing authorisation ofRituximab GP2013. 

We wish to ensure that we are not surprised by actions taken by Sandoz aimed at obtaining marketing authorisation for GP2013 and that those actions will not affect either the clinical trial schedule adopted by Mabion S.A., or the marketing strategy for MabionCD20.

In line with the previously communicated information, Mabion intends to commence the marketing authorisation procedure for MabionCD20 after clinical trials have been concluded.

Considering the current status of its clinical trial, Mabion S.A. confirms that the design of the MabionCD20 clinical programme, including the particularly important safety study range, was consulted with EMA in the scientific advice process on three separate occasions, each time receiving a favourable opinion.

Therefore we consider our clinical trial programme for MabionCD20, participated by over 800 patients, to be sufficient and associated with minimal risk that the application for marketing authorisation is rejected.

On behalf of Mabion S.A.

Maciej Wieczorek, President of the Board

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