We’re experiencing issues with our datasets and search. We apologise for any inconvenience while we work to fix this.
EPIDYOLEX (Emerge Health Pty Ltd)
Product name
EPIDYOLEX
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
140 working days (255)
Active ingredients
cannabidiol
Registration type
NCE/NBE
Indication
EPIDYOLEX (oral solution) is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) for patients 2 years of age and older.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.