ARTG Entry

ERTAPENEM

ARTG entry for ERTAPENEM (ertapenem), ARTG 291480 — Product Information, dosage form, registration history. Compiled by arcimedes.

I appreciate your request, but

I must inform you that the provided source document contains only ARTG registration details (registration numbers, dates, and formulation information) for ERTAPENEM products.

To write a comprehensive Brand Dossier following your specifications, I would need source documents that contain information about: — What ertapenem is (pharmacological class, mechanism of action) — Approved indications for use — Dosing recommendations by indication — Key safety warnings — Contraindications — PBS listing details (strength, item count, restriction type, ex-manufacturer price) — Regulatory history including PBAC outcomes and AusPAR information

The current source only supports minimal factual claims: ERTAPENEM JUNO is a 1 g powder for injection vial formulation of ertapenem sodium, first listed on the ARTG on 17 July 2019. A second variant, ERTAPENEM JN (also 1 g powder for injection), was listed on 24 November 2025. To proceed with the Brand Dossier, please provide: — Product Information or approved label documentation — PBAC submission reports or outcomes — AusPAR or similar regulatory assessment documents — PBS schedule listing details — Any safety or clinical guidance documents

TGA Public Summary — ARTG 291480