Isotopia is excited to announce that Isoprotrace®, the Gallium-68 Gozetotide preparation kit for prostate cancer imaging, has received official marketing authorization in Denmark.
This milestone marks a significant advancement in prostate cancer diagnostics, providing healthcare professionals with an advanced tool to improve the detection and management of prostate cancer.
Isoprotrace® is specifically designed to address the needs of prostate cancer patients. It is indicated* for positron emission tomography (PET) in patients with prostate cancer, for primary staging of those with high-risk disease prior to primary curative therapy, and for patients who have suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels.
Isoprotrace®, a ready-to-use, multi-dose kit, allows for the efficient preparation of Gallium (68Ga) Gozetotide solution for intravenous (I.V.) injection*.
“We are thrilled to receive marketing authorization for Isoprotrace® in Denmark, a critical step in making this innovative diagnostic tool available to healthcare providers and patients,” said Tzachi Levy, General Manager of Isotopia’s aseptic plant. “This achievement underscores our commitment to advancing prostate cancer care and delivering innovative solutions that improve patient outcomes globally.”
CardiRad Oy, our distributor in Denmark, will play a key role in ensuring that Isoprotrace® is accessible to healthcare providers across the region. “We are proud to partner with Isotopia to bring this advanced product to the Danish market,” said John Storbjörk CEO at CardiRad Oy. “Isoprotrace® will provide clinicians with an invaluable tool to enhance prostate cancer diagnosis and patient care.”
Isoprotrace® has already been approved in the Netherlands and Germany and is expected to be available soon in over 10 EU countries. With a robust and reliable supply chain and a proven compliance record, Isotopia is committed to expanding patient access to this innovative product, while enhancing diagnostic accuracy and improving treatment outcomes for prostate cancer.
About Isotopia
Isotopia is a leading innovator in the development of radiopharmaceuticals for molecular imaging and therapy. With a focus on providing top-quality, advanced solutions, Isotopia is committed to improving patient care through precision medicine.
*For detailed indications, please refer to the product’s SmPC.
