EMEA-001964-PIP01-16-M02

Table of contents

Key facts

Invented name
Epidyolex
Active substance
Cannabidiol
Therapeutic area
Neurology
Decision number
P/0350/2020
PIP number
EMEA-001964-PIP01-16-M02
Pharmaceutical form(s)
Oral solution
Condition(s) / indication(s)
  • Treatment of seizures associated with Dravet Syndrome (DS)
  • Treatment of seizures associated with infantile spasms (IS)
  • Treatment of seizures associated with Lennox-Gastaut Syndrome (LGS)
  • Treatment of seizures associated with Tuberous Sclerosis Complex (TSC)
Route(s) of administration
Oral use
Contact for public enquiries
GW Pharma (International) B.V.

E-mail: info@gwpharm.com
Tel: +44 1223266800

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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