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ORKAMBI 150/188 lumacaftor/ivacaftor 150mg/188mg granules sachet - TGA Drug Approval Details
Approvals
/
TGA
/
ORKAMBI 150/188 lumacaftor/ivacaftor 150mg/188mg granules sachet
Approved
STANDARD
ORKAMBI 150/188 lumacaftor/ivacaftor 150mg/188mg granules sachet
Vertex Pharmaceuticals Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
9f4febb4056e49f1
Company
Vertex Pharmaceuticals Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
9f4febb4056e49f1
Product Name
ORKAMBI 150/188 lumacaftor/ivacaftor 150mg/188mg granules sachet
Artg Id
305012
Artg Name
ORKAMBI 150/188 lumacaftor/ivacaftor 150mg/188mg granules sachet
Sponsor
Vertex Pharmaceuticals Australia Pty Ltd
Company Detail Path
/organization/vertex-pharmaceuticals-australia-pty-ltd
Artg Date
2019-06-21
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
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
9f4febb4056e49f1
Type
Standard
Back to TGA Approvals