Basic Information
Epidyolex
Regulatory Information
EMEA/H/C/004675
September 19, 2019
July 25, 2019
18
September 27, 2024
Company Information
Ireland
Fifth Floor Waterloo Exchange Waterloo Road D04 E5W7 Dublin 4
JAZZ PHARMACEUTICALS IRELAND LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older.
Overview Summary
Epidyolex is a medicine used in addition to clobazam, to treat patients from two years of age with Lennox-Gastaut syndrome or Dravet syndrome. It is also used to treat tuberous sclerosis complex (TSC) with other epilepsy treatments in patients also aged two and above. These are rare types of epilepsy that begin in childhood and can continue into adulthood. Symptoms of these conditions include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems. The conditions are rare, and Epidyolex was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency’s website: ( [Dravet syndrome](/en/medicines/human/orphan-designations/eu-3-14-1339): 15 October 2014; [Lennox-Gastaut syndrome](/en/medicines/human/orphan-designations/eu-3-17-1855): 20 March 2017; [tuberous sclerosis](/en/medicines/human/orphan-designations/eu-3-17-1959): 17 January 2018). Epidyolex contains the active substance cannabidiol.