MHRA-100430-PIP01-22

Key Facts

Active Substance
Active Substance:
  • ±3,4-methylenedioxymethamphetamine hydrochloride (MDMA)
Invented Name
Not available at present
PIP Number MHRA-100430-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, hard
Therapeutic area
Therapeutic area:
  • Psychiatry
Conditions / Indications
Conditions / Indications:
  • Treatment of post-traumatic stress disorder
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
  • Multidisciplinary Association for Psychedelic Studies (MAPS) Europe B.V.
  • Country Netherlands
  • Tel +310202101363
  • Email legalrep@mapseurope.eu
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):�3,4-methylenedioxymethamphetamine hydrochloride (MDMA) .pdf
Published Date 24/08/2023