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EPKINLY epcoritamab 48mg/0.8mL solution for injection vial - TGA Drug Approval Details
Approvals
/
TGA
/
EPKINLY epcoritamab 48mg/0.8mL solution for injection vial
Approved
STANDARD
EPKINLY epcoritamab 48mg/0.8mL solution for injection vial
AbbVie Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
7e4985de35b0dd38
Company
AbbVie Pty Ltd
Type
Standard
Approval Details
Approval Id
7e4985de35b0dd38
Product Name
EPKINLY epcoritamab 48mg/0.8mL solution for injection vial
Artg Id
404977
Artg Name
EPKINLY epcoritamab 48mg/0.8mL solution for injection vial
Sponsor
AbbVie Pty Ltd
Company Detail Path
/organization/abbvie-pty-ltd
Artg Date
2025-01-06
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
REP
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/b46588f2f14491d3e3d34048d12df834.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/74860244ff221865d5e3dc382718a8f8.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
7e4985de35b0dd38
Type
Standard
Back to TGA Approvals
