Cannabidiol

Extended indication	Extension of indication to include treatment with Epidyolex (monotherapy) as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of age and older (without the restriction for use only in conjunction with clobazam.
Therapeutic value	No estimate possible yet
Registration phase	No registration expected

Product

Active substance	Cannabidiol
Domain	Neurological disorders
Reason of inclusion	Indication extension
Main indication	Epilepsy
Extended indication	Extension of indication to include treatment with Epidyolex (monotherapy) as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of age and older (without the restriction for use only in conjunction with clobazam.
Proprietary name	Epidyolex
Manufacturer	GW Pharmaceuticals
Mechanism of action	Cannabinoid
Route of administration	Oral
Therapeutical formulation	Solution
Budgetting framework	Extramural (GVS)
Additional remarks	A small-molecule cannabinoid compound

Registration route	Centralised (EMA)
Submission date	September 2022
Orphan drug	No
Registration phase	No registration expected
Additional remarks	De CHMP vond het bewijs niet overtuigend genoeg en zal daarom geen marktauthorisatie afgeven.

Current treatment options	Op dit moment gegeven met enkel gegeven in combinatie met clobazam.
Therapeutic value	No estimate possible yet

There is currently nothing known about the expected patient volume.

There is currently nothing known about the expected cost.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.