Approvals/TGA/TRIKAFTA 80/40/60 GRANULES elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg granules and ivacaftor 59.5 mg granules sachet composite pack

Approved

STANDARD

TRIKAFTA 80/40/60 GRANULES elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg granules and ivacaftor 59.5 mg granules sachet composite pack

Vertex Pharmaceuticals Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Date: May 30, 2025
Approval ID: 9ec6c1adff665f47
Company: Vertex Pharmaceuticals Australia Pty Ltd
Type: Standard

Approval Details

Approval Id: 9ec6c1adff665f47
Product Name: TRIKAFTA 80/40/60 GRANULES elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg granules and ivacaftor 59.5 mg granules sachet composite pack
Artg Id: 402132
Artg Name: TRIKAFTA 80/40/60 GRANULES elexacaftor 80 mg/tezacaftor 40 mg/ivacaftor 60 mg granules and ivacaftor 59.5 mg granules sachet composite pack
Sponsor: Vertex Pharmaceuticals Australia Pty Ltd
Company Detail Path: /organization/vertex-pharmaceuticals-australia-pty-ltd
Artg Date: 2024-02-07
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/666d6e4048671c87ef045a73ec62cfe9.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/137d61f24145f0fe8c3ba81ed27039fb.pdf

Active Ingredients

Approved

Quick Info

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

9ec6c1adff665f47

Type

Standard

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