Reason for request

Indication extension

Summary of opinion

Favourable opinion for reimbursement for pain relief (analgesia) in emergency medicine and pain control in artificial respiration (intubation). 

No clinical added value of ESKETAMINE RENAUDIN (esketamine) 5 and 25 mg/mL compared to the proprietary medicinal product ESKESIA (esketamine) 5 mg/mL and 25 mg/mL solution for
injection/infusion.


Clinical Benefit

Substantial

The Committee considers that the clinical benefit of ESKETAMINE RENAUDIN (esketamine) is substantial in pain relief (analgesia) in emergency medicine.


Clinical Added Value

no clinical added value

These proprietary medicinal products provide no clinical added value (CAV V) compared to ESKESIA (esketamine) 5 and 25 mg/mL solution for injection/infusion.


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