DEXMEDETOMIDINE-AFT (AFT Pharmaceuticals Pty Ltd)
Product name
DEXMEDETOMIDINE-AFT
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
134 (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 Dexmedetomidine-AFT 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.