Epidyolex

cannabidiol

Table of contents

Opinion

On 25 February 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Epidyolex. The marketing authorisation holder for this medicinal product is GW Pharma (International) B.V..

The CHMP adopted a new indication as follows:

Epidyolex is indicated for use as adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older.

For information, the full indications for Epidyolex will be as follows:1

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.

Epidyolex is indicated for use as adjunctive therapy of seizures associated with tuberous sclerosis complex (TSC) for patients 2 years of age and older.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold.

Key facts

Name
Epidyolex
Agency product number
EMEA/H/C/004675
International non-proprietary name (INN) or common name
  • cannabidiol
Active substance
  • Cannabidiol
Therapeutic area
Lennox Gastaut Syndrome
Epilepsies, Myoclonic
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.

Date opinion adopted
25/02/2021
Company name
GW Pharma (International) B.V.
Status
Positive
Application type
Post-authorisation

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