Epidyolex (cannabidiol)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- cannabidiol
- Company
- Jazz Pharmaceuticals Ireland Limited
- Status
- Authorised
- Therapeutic area
- Lennox Gastaut Syndrome; Epilepsies, Myoclonic
- CHMP opinion
- Thu 25 Jul 2019
- EU approval
- Thu 19 Sep 2019
- Designations
- Orphan
- Application
- EMEA/H/C/004675
- ATC
- N03AX
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.