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Xembify
Published
Product name
Xembify
Active ingredient
Normal immunoglobulin human
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Xembify (normal immunoglobulin human) was approved for the following therapeutic use:
Indications for subcutaneous administration (SCIg)
Xembify is indicated as replacement therapy in adult and paediatric patients for:
- Primary immunodeficiency diseases (PID)
- Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.
How this medicine works
Xembify supplies a broad spectrum of opsonising and neutralising immunoglobulin G (IgG) antibodies against bacteria and their toxins. The role of these antibodies and the mechanism of action of IgG in Xembify in primary immunodeficiency diseases (PID) has not been fully elucidated.
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 Xembify was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- XEMBIFY normal immunoglobulin 2 g/10 mL (20%) solution for subcutaneous injection vial (355315)
- XEMBIFY normal immunoglobulin 4 g/20 mL (20%) solution for subcutaneous injection vial (380404)
- XEMBIFY normal immunoglobulin 1 g/5 mL (20%) solution for subcutaneous injection vial (380405)
- XEMBIFY normal immunoglobulin 10 g/50 mL (20%) solution for subcutaneous injection vial (380406)