SPY AGENT GREEN (Stryker Australia Pty Ltd)
Product name
SPY AGENT GREEN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
128 (255 working days)
Active ingredients
indocyanine green
Registration type
NCE/NBE
Indication
For fluorescence imaging use only.
SPY AGENT GREEN (indocyanine green) is an imaging agent (dye) intended for:
- 1.Visualisation of vessels, blood flow and tissue perfusion in adults and paediatricpatients from one month of age and above.
- 2.Visualisation of extrahepatic biliary ducts in adults and children from 12 years ofage and above.
- 3.Visualisation of lymph nodes and lymphatic vessels in women with cervical oruterine solid tumours for which lymphatic mapping is a component ofintraoperative management.