EMEA-002320-PIP01-17-M03 - paediatric investigation plan

Isoflurane

Key facts

• Invented name:
  Sedaconda and associated names
• Active substance:
  Isoflurane
• Therapeutic area:
  Neonatology-Paediatric Intensive Care
• Decision number:
  P/0031/2023
• PIP number:
  EMEA-002320-PIP01-17-M03
• Pharmaceutical form(s):
  Inhalation vapour (liquid)
• Condition(s) / indication(s):
  Sedation of mechanically ventilated patients
• Route(s) of administration:
  Inhalation use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  31/01/2023
• Compliance check done:
  No

Decision

P/0031/2023: EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for isoflurane (Sedaconda and associated names), (EMEA-002320-PIP01-17-M03)

Reference Number: EMA/21188/2023