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EPYZTEK ustekinumab 5 mg/1 mL solution for intravenous infusion injection vial - TGA Drug Approval Details
Approvals
/
TGA
/
EPYZTEK ustekinumab 5 mg/1 mL solution for intravenous infusion injection vial
Approved
STANDARD
EPYZTEK ustekinumab 5 mg/1 mL solution for intravenous infusion injection vial
Samsung Bioepis AU Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
107aa17fec2cda09
Company
Samsung Bioepis AU Pty Ltd
Type
Standard
Approval Details
Approval Id
107aa17fec2cda09
Product Name
EPYZTEK ustekinumab 5 mg/1 mL solution for intravenous infusion injection vial
Artg Id
423023
Artg Name
EPYZTEK ustekinumab 5 mg/1 mL solution for intravenous infusion injection vial
Sponsor
Samsung Bioepis AU Pty Ltd
Company Detail Path
/organization/samsung-bioepis-au-pty-ltd
Artg Date
2024-10-21
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
107aa17fec2cda09
Type
Standard
Back to TGA Approvals