EMEA-002758-PIP01-19-M02 - paediatric investigation plan

Dexmedetomidine hydrochloride

Key facts

• Active substance:
  Dexmedetomidine hydrochloride
• Therapeutic area:
  Psychiatry
• Decision number:
  P/0248/2022
• PIP number:
  EMEA-002758-PIP01-19-M02
• Pharmaceutical form(s):
  Oromucosal film
• Condition(s) / indication(s):
  • Treatment of bipolar disorder
  • Treatment of schizophrenia
• Route(s) of administration:
  Sublingual use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/07/2022
• Compliance check done:
  No

Decision

P/0232/2022: EMA decision of 8 July 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for sibeprenlimab (EMEA-003085-PIP01-21)

Adopted Reference Number: EMA/575972/2022