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SYMTUZA (Janssen-Cilag Pty Ltd)
Product name
SYMTUZA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
184 working days (255)
Active ingredients
darunavir/cobicistat/emtricitabine/tenofovir alafenamide
Registration type
EOI
Indication
New combination
SYMTUZA (film-coated tablets) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). Genotypic testing should guide the use of SYMTUZA (see section 4.2 Dose and method of administration, section 4.4 Special warnings and precautions for use and section 5.1 Pharmacodynamic properties).