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KALYDECO ivacaftor 150mg film-coated tablets bottle - TGA Drug Approval Details
Approvals
/
TGA
/
KALYDECO ivacaftor 150mg film-coated tablets bottle
Approved
STANDARD
KALYDECO ivacaftor 150mg film-coated tablets bottle
Vertex Pharmaceuticals Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 29, 2025
Approval ID
79143e7fa07d35e5
Company
Vertex Pharmaceuticals Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
79143e7fa07d35e5
Product Name
KALYDECO ivacaftor 150mg film-coated tablets bottle
Artg Id
198654
Artg Name
KALYDECO ivacaftor 150mg film-coated tablets bottle
Sponsor
Vertex Pharmaceuticals Australia Pty Ltd
Company Detail Path
/organization/vertex-pharmaceuticals-australia-pty-ltd
Artg Date
2013-07-09
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Product Information
https://medical-cdn.nocode.com/drug_tga/fd45d50a92c5a92b2832d7598a9c5583.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 29, 2025
Approval ID
79143e7fa07d35e5
Type
Standard
Back to TGA Approvals