Approvals/TGA/HADLIMA adalimumab 40 mg/0.4 mL solution for injection in pre-filled syringe

Approved

STANDARD

HADLIMA adalimumab 40 mg/0.4 mL solution for injection in pre-filled syringe

Samsung Bioepis AU Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: cbcc55f70854dad1
Product Name: HADLIMA adalimumab 40 mg/0.4 mL solution for injection in pre-filled syringe
Artg Id: 385133
Artg Name: HADLIMA adalimumab 40 mg/0.4 mL solution for injection in pre-filled syringe
Sponsor: Samsung Bioepis AU Pty Ltd
Company Detail Path: /organization/samsung-bioepis-au-pty-ltd
Artg Date: 2023-02-15
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/afa317378f098952ceea306e1b093db9.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/3a2a0570999fd6263752c1061f3099f4.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

cbcc55f70854dad1

Type

Standard