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.