PBS arrangements due to shortage of tenofovir with emtricitabine tablets
Page last updated: 24 September 2024
Due to the shortage of tenofovir with emtricitabine tablets, the department will be temporarily listing on the PBS an alternative brand, Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/300 mg Tablets (Laurus Labs, USA), from 1 October 2024.
The Therapeutic Goods Administration (TGA) has temporarily approved the supply of an alternate brand, Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/300 mg Tablets (Laurus Labs, USA), under section 19A of the Therapeutic Goods Act 1989 until 31 January 2025. Section 19A (s19A) of the Therapeutic Goods Act 1989 allows overseas-registered medicines not currently included in the Australian Register of Therapeutic Goods (ARTG) to be imported into Australia and supplied in place of a registered medicine that is unavailable or in short supply.
The Laurus Labs brand of tenofovir with emtricitabine is registered in the USA. From 1 October 2024, this brand will be listed on the PBS until the TGA s19A approval lapses. It will be a-flagged to, and listed under the same conditions as the following PBS-listed medicines:
- CIPLA TENOFOVIR/EMTRICITABINE 300/200
- TENOFOVIR/EMTRICITABINE 300/200 ARX
- Tenofovir/Emtricitabine 300/200 APOTEX
- Tenofovir Disoproxil Emtricitabine Viatris 300/200
- Tenofovir/Emtricitabine Sandoz 301/200
