EPIDYOLEX Jazz Pharmaceuticals ANZ Pty Ltd
Product name
EPIDYOLEX
Sponsor
Accepted date
Jun-2026
Active ingredients
cannabidiol
Summary of proposed indication
EPIDYOLEX (cannabidiol) is proposed as an add-on treatment to control seizures in people aged 2 years and older with tuberous sclerosis complex, a rare genetic disorder that causes benign tumours to develop in multiple organs throughout the body.
Application type
C (new indication)
Publication date
Jun-2026
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.