This medicine is authorised for use in the European Union.


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: 15 October 2014; Lennox-Gastaut syndrome: 20 March 2017; tuberous sclerosis: 17 January 2018).

Epidyolex contains the active substance cannabidiol.

This EPAR was last updated on 04/07/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Lennox Gastaut Syndrome
  • Epilepsies, Myoclonic
Anatomical therapeutic chemical (ATC) code

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Jazz Pharmaceuticals Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Fifth Floor Waterloo Exchange
Waterloo Road
D04 E5W7
Dublin 4

Product information

31/05/2023 Epidyolex - EMEA/H/C/004675 - T/0026

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


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.

Assessment history

Changes since initial authorisation of medicine

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