Approvals/TGA/ORKAMBI 200/125 lumacaftor/ivacaftor 200mg/125mg film-coated tablet blister pack

Approved

STANDARD

ORKAMBI 200/125 lumacaftor/ivacaftor 200mg/125mg film-coated tablet blister pack

Vertex Pharmaceuticals Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 6ce348112b8afaef
Product Name: ORKAMBI 200/125 lumacaftor/ivacaftor 200mg/125mg film-coated tablet blister pack
Artg Id: 235759
Artg Name: ORKAMBI 200/125 lumacaftor/ivacaftor 200mg/125mg film-coated tablet blister pack
Sponsor: Vertex Pharmaceuticals Australia Pty Ltd
Company Detail Path: /organization/vertex-pharmaceuticals-australia-pty-ltd
Artg Date: 2016-03-08
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/8f2d0c2d7ee02901147e79f4ed065780.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/99c7a7fdc709e720071a3ee6cd0833d1.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

6ce348112b8afaef

Type

Standard