EMEA-002052-PIP02-23 - paediatric investigation plan

deutetrabenazine

Key facts

• Active Substance:
  deutetrabenazine
• Therapeutic area:
  Neurology
• Decision number:
  P/0205/2023
• PIP number:
  EMEA-002052-PIP02-23
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of tardive dyskinesia
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Teva B.V.

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/06/2023

Decision

P/0205/2023 : EMA decision of 14 June 2023 on the granting of a product specific waiver for deutetrabenazine (EMEA-002052-PIP02-23)

Reference Number: EMA/253093/2023