PBS arrangements due to shortage of tenofovir with emtricitabine tablets
24 Sep 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
