DEXDOR (Orion Pharma (AUS) Pty Limited)
Product name
DEXDOR
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
165 (255 working days)
Active ingredients
Dexmedetomidine hydrochloride
Registration type
New generic medicine
Indication
Intensive Care Unit (ICU) Sedation
For sedation of initially intubated patients during treatment in an intensive care setting. The use of DEXDOR by continuous infusion in these patients should not exceed 24 hours.
Procedural Sedation
For sedation of non-intubated patients prior to and/or during surgical and other procedures.