Agilus (dantrolene sodium, hemiheptahydrate)
- Region
- 🇪🇺 EU
- Active substance
- dantrolene sodium, hemiheptahydrate
- Company
- Norgine B.V.
- Status
- Authorised
- Therapeutic area
- Malignant Hyperthermia
- CHMP opinion
- Thu 21 Mar 2024
- EU approval
- Wed 29 May 2024
- Application
- EMEA/H/C/006009
- ATC
- M03CA01
- Official record
- www.ema.europa.eu
Indication
In combination with adequate support measures, Agilus is indicated for the treatment of malignant hyperthermia in adults and children of all ages.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.