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Cutaquig
Published
Product name
Cutaquig
Active ingredient
Human normal immunoglobulin (human immunoglobulin G)
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Cutaquig (human normal immunoglobulin) was approved for the following therapeutic use:
Replacement therapy in adults and children in:
- Primary immunodeficiency diseases (PID)
- Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment
How this medicine works
Cutaquig contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents. It contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donations. Cutaquig has a distribution of IgG subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low IgG levels to the normal range.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Cutaquig was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- CUTAQUIG 8g/48mL Human Normal Immunoglobulin 16.5% solution for subcutaneous injection vial (333120)
- CUTAQUIG 3.3g/20mL Human Normal Immunoglobulin 16.5% solution for subcutaneous injection vial (333121)
- CUTAQUIG 4g/24mL Human Normal Immunoglobulin 16.5% solution for subcutaneous injection vial (333122)
- CUTAQUIG 1g/6mL Human Normal Immunoglobulin 16.5% solution for subcutaneous injection vial (333123)
- CUTAQUIG 2g/12mL Human Normal Immunoglobulin 16.5% solution for subcutaneous injection vial (333124)
- CUTAQUIG 1.65g/10mL Human Normal Immunoglobulin 16.5% solution for subcutaneous injection vial (333125)