28.03.2024,
2620 Zeichen
Petach Tikva, Israel (ots/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...
For more information, please connect with us:
Mail: isoprotrace@isotopia-global.com
Nadav
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-imaging-ltd-is-thrilled-to-announce-that-isoprotrace-has-received-ma
rketing-authorization-in-the-netherlands-rvg-130527-302102313.html
Digital press kit:
http://www.ots.at/pressemappe/PR171734/aom
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