MHRA-101995-PIP01-25-M01 (update)

Key Facts

Active Substance
Active Substance:
  • ISOFLURANE
Invented Name
Sedaconda and associated names
PIP Number MHRA-101995-PIP01-25-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Inhalation vapour, liquid
Therapeutic area
Therapeutic area:
  • Other: Sedation
Conditions / Indications
Conditions / Indications:
  • Sedation of mechanically ventilated patients
Route(s) of administration
Route(s) of administration:
  • Inhalation use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
27/06/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101995-PIP01-25-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):ISOFLURANE.pdf
Published Date 13/08/2025