ARTG Entry

ZEFFIX

ARTG entry for ZEFFIX (lamivudine), ARTG 66828 — Product Information, dosage form, registration history. Compiled by arcimedes.

What it is

ZEFFIX is a lamivudine tablet formulation registered on the Australian Register of Therapeutic Goods. The 100 mg tablet strength is available in blister pack form.

Approved indications

ZEFFIX lamivudine 100 mg tablets are registered on the ARTG, with registration first listed in 1999. The product information documents provided do not contain specific approved indications for the ZEFFIX brand formulation.

Dosing overview

The provided source documents do not contain dosing information specific to the ZEFFIX brand.

Key safety warnings

Lamivudine is a nucleoside reverse transcriptase inhibitor used in antiretroviral therapy. Prescribers should refer to the full product information for the ZEFFIX brand and consult with physicians experienced in HIV management before initiating treatment.

Contraindications

The provided source documents do not contain contraindication information specific to the ZEFFIX brand formulation.

PBS listing

ZEFFIX lamivudine 100 mg tablets are listed on the PBS with one item number, restriction type streamlined, and an ex-manufacturer price of A$24.62.

Regulatory history

ZEFFIX lamivudine 100 mg tablets in blister pack form were first listed on the ARTG on 18 May 1999 under licence category RE. A lamivudine 5 mg/mL oral solution variant was also registered on the same date.

TGA Public Summary — ARTG 66828