Approvals/TGA/TRIKAFTA 50/25/37.5 elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg film-coated tablet and ivacaftor 75 mg film-coated tablet blister pack composite pack

Approved

STANDARD

TRIKAFTA 50/25/37.5 elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg film-coated tablet and ivacaftor 75 mg film-coated tablet blister pack composite pack

Vertex Pharmaceuticals Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Date: May 30, 2025
Approval ID: 90bec02d414b4bb4
Company: Vertex Pharmaceuticals Australia Pty Ltd
Type: Standard

Approval Details

Approval Id: 90bec02d414b4bb4
Product Name: TRIKAFTA 50/25/37.5 elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg film-coated tablet and ivacaftor 75 mg film-coated tablet blister pack composite pack
Artg Id: 372334
Artg Name: TRIKAFTA 50/25/37.5 elexacaftor 50mg/tezacaftor 25mg/ivacaftor 37.5mg film-coated tablet and ivacaftor 75mg film-coated tablet blister composite pack
Sponsor: Vertex Pharmaceuticals Australia Pty Ltd
Company Detail Path: /organization/vertex-pharmaceuticals-australia-pty-ltd
Artg Date: 2022-11-01
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-CMI-01349-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-PI-01350-1

Active Ingredients

Approved

Quick Info

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

90bec02d414b4bb4

Type

Standard

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