EMEA-002320-PIP01-17-M03 - paediatric investigation plan
Isoflurane
PIPHuman
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
Contact for public enquiries
Sedana Medical AB
regulatoryaffairs@sedanamedical.com
+46 707710364
Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
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)