Approvals/TGA/BIKTARVY bictegravir (as sodium) 50 mg, emtricitabine 200 mg, tenofovir alafenamide (as fumarate) 25 mg fixed-dose combination tablets blister pack

Approved

STANDARD

BIKTARVY bictegravir (as sodium) 50 mg, emtricitabine 200 mg, tenofovir alafenamide (as fumarate) 25 mg fixed-dose combination tablets blister pack

Gilead Sciences Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Date: May 30, 2025
Approval ID: 84cd76ea76f6fa6f
Company: Gilead Sciences Pty Ltd
Type: Standard

Approval Details

Approval Id: 84cd76ea76f6fa6f
Product Name: BIKTARVY bictegravir (as sodium) 50 mg, emtricitabine 200 mg, tenofovir alafenamide (as fumarate) 25 mg fixed-dose combination tablets blister pack
Artg Id: 365510
Artg Name: BIKTARVY bictegravir (as sodium) 50 mg, emtricitabine 200 mg, tenofovir alafenamide (as fumarate) 25 mg fixed-dose combination tablets blister pack
Sponsor: Gilead Sciences Pty Ltd
Company Detail Path: /organization/gilead-sciences-pty-limited
Artg Date: 2021-08-02
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/77d426f88e481f76f88bb376ae4a6c61.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/346743f14299ebc769fec95526a7ae35.pdf

Active Ingredients

Approved

Quick Info

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

84cd76ea76f6fa6f

Type

Standard

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