Agilus Norgine B.V. · Authorised · authorised 29 May 2024 · ATC M03CA01
Therapeutic indication (EMA)
In combination with adequate support measures, Agilus is indicated for the treatment of malignant hyperthermia in adults and children of all ages.
Active substance
Dantrolene sodium hemiheptahydrate
- EMA 1
- UK MHRA 1
EMA European Union — centrally authorised medicines
UK MHRA United Kingdom — marketing authorisations
| Product | Authorisation | Holder | Legal status |
|---|---|---|---|
| AGILUS 120 MG POWDER FOR SOLUTION FOR INJECTION | PLGB 20011/0075 | NORGINE PHARMACEUTICALS LIMITED | POM |
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.