AGILUS (dantrolene sodium hemiheptahydrate) - Hyperthermia

Opinions on drugs - Posted on Feb 13 2025

Reason for request

Initial inclusion

Summary of opinion

Favourable opinion for reimbursement in the treatment of malignant hyperthermia in adults and children of all ages in combination with adequate support measures.

Clinical Benefit

Substantial

The clinical benefit of AGILUS powder for solution for injection (dantrolene sodium hemiheptahydrate) is substantial in the MA indication.

Clinical Added Value

no clinical added value

This medicinal product is a hybrid that does not provide any clinical added value (CAV V) compared to the reference medicinal product, DANTRIUM IV, lyophilisate for solution for injection (dantrolene sodium), already listed.