Reason for request

Initial inclusion

Summary of opinion

Favourable opinion for reimbursement in the indication sedation in palliative care.

No clinical added value compared to the other generic medicinal products containing midazolam for injection already available in this indication (MIDAZOLAM ACCORD, solution for injection and MIDAZOLAM VIATRIS, solution for injection or rectal use).


Clinical Benefit

Substantial

The Committee considers that the clinical benefit of MIDAZOLAM AGUETTANT (midazolam) solution for injection is substantial in sedation in palliative care.


Clinical Added Value

no clinical added value

This medicinal product provides no clinical added value (CAV V) compared to the other generic medicinal products containing midazolam for injection already listed (MIDAZOLAM ACCORD solution for injection, and MIDAZOLAM VIATRIS solution for injection or rectal use) in the care pathway for sedation in palliative care.