Epidyolex
cannabidiol
Table of contents
Overview
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.
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List item
Epidyolex : EPAR - Medicine overview (PDF/128.17 KB)
First published: 04/10/2019
Last updated: 26/04/2021
EMA/191061/2021 -
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Epidyolex : EPAR - Risk-management-plan summary (PDF/315.27 KB)
First published: 04/10/2019
Last updated: 26/04/2021
Authorisation details
Product details | |
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Name |
Epidyolex
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Agency product number |
EMEA/H/C/004675
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Active substance |
Cannabidiol
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International non-proprietary name (INN) or common name |
cannabidiol
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
N03AX
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Orphan |
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 | |
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Marketing-authorisation holder |
Jazz Pharmaceuticals Ireland Limited
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Revision |
15
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Date of issue of marketing authorisation valid throughout the European Union |
19/09/2019
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Contact address |
Fifth Floor Waterloo Exchange |
Product information
31/05/2023 Epidyolex - EMEA/H/C/004675 - T/0026
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 202326/04/2023
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26/02/2021
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26/07/2019