MHRA-100151-PIP01-21

Key Facts

Active Substance
Active Substance:
  • CANNABIDIOL
Invented Name
  • Epidyolex
  • Epidyolex
  • Epidyolex
  • Epidiolex
  • Epidyolex
  • Epidyolex
  • Epidiolex
PIP Number MHRA-100151-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Oral solution
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of epilepsy with myoclonic-atonic seizures (EMAS)
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • GW Research UK Ltd
  • Country United Kingdom
  • Tel 00441223266800
  • Email gwreg@gwpharm.com
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CANNABIDIOL.pdf
Published Date 27/09/2022