Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Section 19A Approval – Now Available from Pro Pharmaceuticals Group
- Sandip Manku
- Nov 7
- 1 min read
Dear Healthcare Professional,
Pro Pharmaceuticals Group wishes to advise that the Australian registered product TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ Viatris 300/200/600 (AUST R: 280721) is currently in shortage, as listed on the TGA Medicines Shortage Database.
To ensure continuity of care, the TGA has granted approval under Section 19A of the Therapeutic Goods Act 1989 for supply of an alternative product:
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 600mg/200mg/300mg (Camber Pharmaceuticals, USA)
This product is registered and marketed in the United States and is approved for import and supply in Australia until 31 May 2026, specifically for the treatment of HIV-1 infection in adults over the age of 18 years.
Key Details
Equivalent active ingredients and strength to the Australian registered product
Registered in the USA (ANDA 203053)
Supplied as film-coated tablets in bottles of 30
Labelled in English
Manufactured by Annora Pharma Private Limited (FDA-registered site)
We encourage hospital pharmacies, infectious disease units, and community pharmacy providers to circulate this information internally and contact us regarding stock availability.
📧 Orders & Enquiries: orders@propg.com.au📞 Phone: 1300 077 674🌐 Website: www.propg.com.au
