Approvals/TGA/EPYZTEK ustekinumab 45 mg/0.5mL solution for injection pre-filled syringe

Approved

STANDARD

EPYZTEK ustekinumab 45 mg/0.5mL solution for injection pre-filled syringe

Samsung Bioepis AU Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: c2a0fff952018416
Product Name: EPYZTEK ustekinumab 45 mg/0.5mL solution for injection pre-filled syringe
Artg Id: 423022
Artg Name: EPYZTEK ustekinumab 45 mg/0.5mL solution for injection pre-filled syringe
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

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

c2a0fff952018416

Type

Standard