Epidyolex

RSS

cannabidiol

Authorised
This medicine is authorised for use in the European Union.

Overview

Epidyolex is a medicine used in addition to clobazam, another epilepsy medicine, to treat patients from the age of two years who have Lennox-Gastaut syndrome or Dravet syndrome, rare types of epilepsy that begin in childhood and can continue into adulthood.

Symptoms include multiple types of seizure (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.

These 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).

Epidyolex contains the active substance cannabidiol.

This EPAR was last updated on 04/10/2019

Authorisation details

Product details
Name
Epidyolex
Agency product number
EMEA/H/C/004675
Active substance
Cannabidiol
International non-proprietary name (INN) or common name
cannabidiol
Therapeutic area (MeSH)
  • Lennox Gastaut Syndrome
  • Epilepsies, Myoclonic
Anatomical therapeutic chemical (ATC) code
N03AX
OrphanOrphan

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
GW Pharma (International) B.V.
Date of issue of marketing authorisation valid throughout the European Union
19/09/2019
Contact address

Databankweg 26
3821AL Amersfoort
Netherlands

Product information

19/09/2019 Epidyolex - EMEA/H/C/004675 - EMEA/H/C/004675

Contents

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Pharmacotherapeutic group

Antiepileptics

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

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