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Verdye (indocyanine green)

Australian Prescription Medicine Decision Summary
Published
Product name
Verdye
Active ingredient
Indocyanine Green
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for

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
How this medicine works

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.

Consumer Medicine Information (CMI)

The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more. 

The Australian CMIs can be accessed through the ARTG details hyperlink below.

Product Information (PI)

The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.

The Australian PIs can be accessed through the ARTG details hyperlink below.

Australian Public Assessment Report (AusPAR)

AusPARs provide detailed information about the TGA’s assessment of prescription medicine registration applications. They outline the evidence submitted to the TGA and the considerations that informed the decision to approve or not approve the medicine for registration in Australia.

We aim to publish AusPARs within 3 months of the TGA’s decision.

Search AusPARs

Sponsor
Regulatory Approval Services Pty Ltd
ARTG details
Other resources

For health advice and information, including a symptom checker and service finder refer to the healthdirect website.

For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.

For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.

For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.

Related TGA resources

Find more information about AusPMDSs at About Australian Prescription Medicine Decision Summaries (AusPMDSs).

Find more information about AusPARs at About Australian Public Assessment Reports (AusPARs) for prescription medicines

Search the Australian Register of Therapeutic Goods (ARTG) by product name, ARTG ID or sponsor.

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