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KALDENN (chlorure de rubidium (82Rb)) - Diagnostic use
Reason for request
Summary of opinion
Favourable opinion for reimbursement: “This medicinal product is for diagnostic use only. The generator eluate (solution of rubidium-82 (Rb-82) chloride for injection) is used for Positron Emission Tomography (PET) imaging of the myocardium at rest or under
pharmacologic stress conditions to evaluate regional myocardial perfusion in adults with suspected or known coronary artery disease (CAD).”
Clinical Benefit
| Substantial |
The Committee deems that the clinical benefit of KALDENN (rubidium-82) chloride) is substantial in the MA indication. |
Clinical Added Value
| no clinical added value |
The Committee considers that KALDENN (rubidium-82 chloride) provides no clinical added value (CAV V) compared to the other proprietary medicinal product containing rubidium-82 chloride (CARDIOGEN-82) already listed in the same indication (the generator eluate (solution of rubidium-82 (Rb-82) chloride for injection) is used for Positron Emission Tomography (PET) imaging of the myocardium at rest or under pharmacologic stress conditions to evaluate regional myocardial perfusion in adults with suspected or known coronary artery disease (CAD)). |
