The first cannabidiol containing medicinal product with a positive opinion in the EU centralised procedure!
- 22 августа 2019
- cannabidiol, cannabis, CBD, centralised procedure, CHMP, clobazam, CP, Dravet syndrome, DS, EMA, Epidyolex, epilepsy, EU, GW Pharma (International) B.V., Lennox-Gastaut syndrome, LGS, MA, MAH, marketing authorization, medicinal product, oral solution, orphan designation, orphan medicine, seizures,
On 25 July 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Epidyolex, intended for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), two forms of epilepsy. The applicant for this medicinal product is GW Pharma (International) B.V.
Epidyolex will be available as 100 mg/ml oral solution. The active substance of Epidyolex is cannabidiol, an antiepileptic (ATC code: N03AX). Epidyolex contains an active substance derived from cannabis and is the first to receive a positive opinion in the EU centralised procedure.
The full indication is: “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”. It is proposed that Epidyolex should be initiated and supervised by physicians with experience in the treatment of epilepsy.
This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.