Telix Submits European Marketing Authorisation Application for Prostate Cancer Imaging Product
Melbourne (Australia) and Liège (Belgium) – 1st May 2020. Telix has submitted a marketing authorisation application (MAA) in Europe for TLX591-CDx
Telix Pharmaceuticals Limited is pleased to announce that it has submitted a marketing authorisation application (MAA) in Europe for TLX591-CDx (68Ga-PSMA-11 Injection) for the imaging of prostate cancer with Positron Emission Tomography (PET).
The submission has been made to the Danish Medicines Agency (DKMA) in its capacity as a reference Competent Authority of a European member state. The DKMA will coordinate and lead the evaluation of Telix’s MAA for TLX591-CDx on behalf of Denmark as well as a selection of European countries, nominated by Telix. These countries reflect the major European markets for Telix’s prostate cancer imaging product.
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