Approvals/TGA/EPKINLY epcoritamab 4mg/0.8mL concentrate solution for injection vial

Approved

STANDARD

EPKINLY epcoritamab 4mg/0.8mL concentrate solution for injection vial

AbbVie Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: e6bb336609104070
Product Name: EPKINLY epcoritamab 4mg/0.8mL concentrate solution for injection vial
Artg Id: 404978
Artg Name: EPKINLY epcoritamab 4mg/0.8mL concentrate 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

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 29, 2025

Approval ID

e6bb336609104070

Type

Standard