EMEA-003283-PIP01-22 - paediatric investigation plan

dexmedetomidine

Key facts

• Active substance:
  dexmedetomidine
• Therapeutic area:
  Anaesthesiology
• Decision number:
  P/0362/2023
• PIP number:
  EMEA-003283-PIP01-22
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Sedation
• Route(s) of administration:
  Intranasal use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Compliance check done:
  No

Decision

P/0362/2023 : EMA decision of 8 September 2023 on the agreement of a paediatric investigation plan for dexmedetomidine (EMEA-003283-PIP01-22)