Approvals/TGA/TRIKAFTA 100/50/75 elexacaftor 100 mg / tezacaftor 50 mg / ivacaftor 75 mg film-coated tablet and ivacaftor 150 mg film-coated tablet blister composite pack

Approved

STANDARD

TRIKAFTA 100/50/75 elexacaftor 100 mg / tezacaftor 50 mg / ivacaftor 75 mg film-coated tablet and ivacaftor 150 mg film-coated tablet blister composite pack

Vertex Pharmaceuticals Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Date: May 30, 2025
Approval ID: ee201d14f6b56716
Company: Vertex Pharmaceuticals Australia Pty Ltd
Type: Standard

Approval Details

Approval Id: ee201d14f6b56716
Product Name: TRIKAFTA 100/50/75 elexacaftor 100 mg / tezacaftor 50 mg / ivacaftor 75 mg film-coated tablet and ivacaftor 150 mg film-coated tablet blister composite pack
Artg Id: 330423
Artg Name: TRIKAFTA 100/50/75 elexacaftor 100mg/tezacaftor 50mg/ivacaftor 75mg film-coated tablet and ivacaftor 150mg film-coated tablet blister composite pack
Sponsor: Vertex Pharmaceuticals Australia Pty Ltd
Company Detail Path: /organization/vertex-pharmaceuticals-australia-pty-ltd
Artg Date: 2021-03-24
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

ee201d14f6b56716

Type

Standard

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