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

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