MHRA-101426-PIP01-24

Key Facts

Active Substance
Active Substance:
  • Deutetrabenazine
Invented Name
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
  • Austedo
PIP Number MHRA-101426-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Tablet
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of tardive dyskinesia
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(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):Deutetrabenazine.pdf
Published Date 28/11/2024