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.
Logo:
https://mma.prnewswire.com/media/2337282/4537248/Isotopia_Logo.jpg
For more information, please connect with us:
Mail: isoprotrace@isotopia-global.com
Nadav
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