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EPIDYOLEX (Emerge Health Pty Ltd)

Product name
Date registered
Evaluation commenced
Decision date
Approval time
140 working days (255)
Active ingredients
Registration type

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.

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