PETACH TIKVA, Israel, March 28, 2024 /PRNewswire/ — Isotopia Molecular Imaging Ltd. is thrilled to announce that Isoprotrace®, our PSMA -11 kit, has received marketing authorization in the Netherlands (RVG 130527). This landmark approval marks a significant milestone in our ongoing commitment to improve healthcare and patient outcomes across the globe.
Isotopia is a radiopharmaceutical focused company with proven expertise in developing, manufacturing, and commercializing pioneering diagnostic and therapeutic products, serving the nuclear medicine market. We appreciate Billev Pharma support as our marketing authorization holder.
Isoprotrace® is designed to address prostate cancer patients. Isoprotrace® is indicated* for positron emission tomography (PET) in patients with prostate cancer, for primary staging of those with high-risk prior to primary curative therapy and patients who have suspected recurrence based on elevated serum prostate specific antigen (PSA) level.
Isoprotrace® is a single sterile vacuum – vial kit, intended for preparing multi-patient doses of Gallium (68Ga) Gozetotide (PSMA -11) within only 5 minutes, saving precious decay time in comparison to a standard synthesis.
“Our isoprotrace® PSMA-11 represents a paradigm shift toward registered and GMP products in nuclear medicine. We have reached this achievement after years of dedicated research and navigating the complex regulatory landscape. It is with immense pride and excitement to be part of this transition. We are humbled by the opportunity and looking forward to our next challenges in this area. This is a testimony to our relentless commitment to patients around the world to supply radiopharmacy products in GMP standard,” said Tzachi Levy, General Manager of Isotopia’s aseptic plant.
Isotopia Molecular Imaging Ltd, is committed to working closely with healthcare providers, regulators, and the patient community in the Netherlands to ensure that Isoprotrace® is accessible to all who can benefit from it. We are also actively pursuing marketing authorizations in other countries (approval is pending for Germany) aiming to make Isoprotrace® available across Europe.
*For detailed information, please refer to the product’s SmPC.
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