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RENFLEXIS infliximab 100 mg powder for injection vial - TGA Drug Approval Details
Approvals
/
TGA
/
RENFLEXIS infliximab 100 mg powder for injection vial
Approved
STANDARD
RENFLEXIS infliximab 100 mg powder for injection vial
Samsung Bioepis AU Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
f4227d89b8ee6fa8
Company
Samsung Bioepis AU Pty Ltd
Type
Standard
Approval Details
Approval Id
f4227d89b8ee6fa8
Product Name
RENFLEXIS infliximab 100 mg powder for injection vial
Artg Id
260410
Artg Name
RENFLEXIS infliximab 100 mg powder for injection vial
Sponsor
Samsung Bioepis AU Pty Ltd
Company Detail Path
/organization/samsung-bioepis-au-pty-ltd
Artg Date
2016-11-28
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/fe5ca0f380f12b3f3d89218dfe659427.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/caf5933ab70fb3d411f96f1b5daf8c35.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
f4227d89b8ee6fa8
Type
Standard
Back to TGA Approvals