TANOREN (noradrenaline tartrate) - Perioperative arterial

The clinical benefit of TANOREN 0.5 mg/mL (noradrenaline tartrate), concentrate for solution for injection/infusion is substantial in the MA indication.

Considering:

• the limited data from the literature demonstrating the efficacy of diluted noradrenaline in restoring and maintaining perioperative arterial pressure following hypotension induced by spinal or general anaesthesia in adults;
• the established medical use of diluted noradrenaline in perioperative arterial pressure control;
• a known safety profile, deemed to be acceptable to date, noradrenaline being a treatment routinely used by professionals working in an emergency setting, in the operating theatre or in an intensive care/resuscitation unit;

but in view of:

• the modest effect size observed with diluted noradrenaline compared to the alternatives, including in robust clinical trials;
• the lack of specific efficacy and safety data for the proprietary medicinal product TANOREN 0.5 mg/mL (noradrenaline tartrate), concentrate for solution for injection/infusion, particularly versus the other vasopressors;

the Committee deems that TANOREN 0.5 mg/mL (noradrenaline tartrate), concentrate for solution for injection/infusion provides no clinical added value (CAV V)compared to the other vasopressors available in France.