Approvals/TGA/SYMDEKO 50/75 tezacaftor 50 mg/ivacaftor 75 mg film-coated tablet and ivacaftor 75 mg film-coated tablet composite pack

Approved

STANDARD

SYMDEKO 50/75 tezacaftor 50 mg/ivacaftor 75 mg film-coated tablet and ivacaftor 75 mg film-coated tablet composite pack

Vertex Pharmaceuticals Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 0d1f210a58348b1d
Product Name: SYMDEKO 50/75 tezacaftor 50 mg/ivacaftor 75 mg film-coated tablet and ivacaftor 75 mg film-coated tablet composite pack
Artg Id: 337367
Artg Name: SYMDEKO 50/75 tezacaftor 50 mg/ivacaftor 75 mg film-coated tablet and ivacaftor 75 mg film-coated tablet composite pack
Sponsor: Vertex Pharmaceuticals Australia Pty Ltd
Company Detail Path: /organization/vertex-pharmaceuticals-australia-pty-ltd
Artg Date: 2021-04-29
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/1fb4a0672332c2ca31e4073027c07a03.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/873d92d25e379df96c160c0a3f7c7508.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

0d1f210a58348b1d

Type

Standard