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Verdye (indocyanine green)
Australian Prescription Medicine Decision Summary
Device/Product name
Verdye
Active Ingredient
Indocyanine Green
Date of decision
Published
Submission type
New chemical entity
Decision
Approved
What steps were involved in the decision process
The following table summarises the key steps and dates for this application.
Description | Date |
|---|---|
Submission dossier accepted and first round evaluation commenced | 1 August 2022 |
First round evaluation completed | 25 January 2023 |
Second round evaluation completed | 4 January 2024 |
Advisory Committee meeting | 16 February 2024 |
Registration decision (Outcome) | 21 February 2024 |
Completion of administrative activities and registration on ARTG | 15 March 2024 |
Number of working days from submission dossier acceptance to registration decision* | 415 days |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Black triangle scheme
Yes
Dose forms
Powder for injection
Strength
25 mg
Containers
Vial, Glass Type I Coloured
Pack sizes
5 vials
Routes of administration
Intravenous
Dosage
Cardiac, circulatory, micro-circulatory and tissue perfusion diagnostics as well as cerebral blood flow: 0.1 to 0.3 mg/kg body weight as bolus injection Liver function diagnostics: 0.25 – 0.5 mg/kg body weight as bolus injection Ophthalmic angiography: 0.1 to 0.3 mg/kg body weight as bolus injection. Total daily dose: Adults, elderly, adolescents 11-18 years: The total daily dose of VERDYE should be kept below 5 mg/kg body weight. Children 2 – 11 years: The total daily dose should be kept below 2.5 mg/kg body weight. Children 0 - 2 years: The total daily dose should be kept below 1.25 mg/kg body weight. |
Pregnancy category
Data on a limited number (242) of exposed pregnancies indicate no adverse effects of Indocyanine green on pregnancy or on the health of the fetus/newborn child. To date, no other relevant epidemiological data are available. No embyrofetal development studies in animals are available. The potential risk for humans is unknown.
Caution should be exercised when prescribing to pregnant women. VERDYE should be given to a pregnant woman only if clearly indicated. Repeated applications on one day have to be avoided.
Caution should be exercised when prescribing to pregnant women. VERDYE should be given to a pregnant woman only if clearly indicated. Repeated applications on one day have to be avoided.
What was approved
VERDYE (indocyanine green) was approved for the following diagnostic indications:
Cardiac, circulatory and micro-circulatory diagnostics:
- measurement of cardiac output and stroke volume
- measurement of circulating blood volumes
- measurement of cerebral perfusion
Liver function diagnostics:
- measurement of liver blood flow
- measurement of excretory function of the liver
Ophthalmic angiography diagnostics:
- measurement of perfusion of the choroid
What is this medicine and how does it work
Indocyanine green is a non-toxic medical dye that is injected intravenously and is used to measure certain cardiac, circulatory and liver functions. It may also aid visualisation of certain eye structures.
What post-market commitments will the sponsor undertake
VERDYE (indocyanine green) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicine Information (CMI) for VERDYE must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
More information
The latest PI and CMI can be found through an ARTG search.
Australian Public Assessment Reports (AusPARs)
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