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Approvals
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TGA
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TREMFYA guselkumab 200 mg / 2 mL solution for injection, pre-filled pen (auto-injector)
Approved
STANDARD
TREMFYA guselkumab 200 mg / 2 mL solution for injection, pre-filled pen (auto-injector)
Janssen-Cilag Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
bc5b9dcf61210dbf
Company
Janssen-Cilag Pty Ltd
Type
Standard
Approval Details
Approval Id
bc5b9dcf61210dbf
Product Name
TREMFYA guselkumab 200 mg / 2 mL solution for injection, pre-filled pen (auto-injector)
Artg Id
460499
Artg Name
TREMFYA guselkumab 200 mg / 2 mL solution for injection, pre-filled pen (auto-injector)
Sponsor
Janssen-Cilag Pty Ltd
Company Detail Path
/organization/janssen-cilag-pty-ltd
Artg Date
2025-07-17
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
bc5b9dcf61210dbf
Type
Standard
Back to TGA Approvals
TREMFYA guselkumab 200 mg / 2 mL solution for injection, pre-filled pen (auto-injector) - TGA Drug Approval Details