Product Dossier
SYMTUZA
Product Dossier for SYMTUZA (cobicistat, darunavir, emtricitabine, tenofovir alafenamide, Janssen-Cilag). ARTG record, PBS listing, PBAC outcomes —…
- Sponsor: Janssen-Cilag
- Active ingredient: cobicistat, darunavir, emtricitabine, tenofovir alafenamide
- Therapeutic area: Infectious Disease
- Related brand: EVOTAZ
- Related brand: PREZCOBIX
- Related brand: PREZISTA
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
SYMTUZA is a film-coated tablet containing 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide.
Approved indications
— Human immunodeficiency virus (HIV) infection.
Key safety warnings
The product information documents provided do not contain safety information specific to SYMTUZA. Prescribers should consult the current product information for SYMTUZA and relevant HIV treatment guidelines for comprehensive safety advice.
PBS listing
SYMTUZA 800/150/200/10 mg is listed on the PBS with an Authority Required (Streamlined) restriction as part of the Highly Specialised Drugs Program — Community Access, on a weighted cost minimisation basis with alternative treatments.
Regulatory history
SYMTUZA was registered on the Australian Register of Therapeutic Goods on 22 November 2019. In November 2019, the Pharmaceutical Benefits Scheme Advice Committee recommended it for listing for the treatment of human immunodeficiency virus (HIV) infection.