ARTG Entry

HAVRIX

ARTG entry for HAVRIX (Hepatitis a virus antigen), ARTG 147331 — Product Information, dosage form, registration history. Compiled by arcimedes.

I cannot write a

Brand Dossier for HAVRIX based on the provided documents. The source material describes TWINRIX (a combined hepatitis A and hepatitis B vaccine), not HAVRIX (a hepatitis A-only vaccine).

While document 2 confirms that HAVRIX is registered on the ARTG as a hepatitis A vaccine in two formulations, the detailed product information needed to populate the required sections of the dossier—such as approved indications, dosing schedules, safety warnings, contraindications, PBS listing details, and regulatory history—is not contained in either provided document.

To produce an accurate and properly cited Brand Dossier for HAVRIX, I would need access to: — HAVRIX product information or SmPC (Summary of Product Characteristics) — HAVRIX PBS listing details (if applicable) — HAVRIX regulatory history and AusPAR documentation — HAVRIX safety and efficacy data

I recommend providing the HAVRIX product information document or directing me to the relevant ARTG entry for HAVRIX specifically.

TGA Public Summary — ARTG 147331