Approvals/TGA/TREMFYA guselkumab (rch) 100 mg solution for injection pre-filled pen (One-Press (R) patient controlled injector)

Approved

STANDARD

TREMFYA guselkumab (rch) 100 mg solution for injection pre-filled pen (One-Press (R) patient controlled injector)

Janssen-Cilag Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 7984cdd1bb71a8e5
Product Name: TREMFYA guselkumab (rch) 100 mg solution for injection pre-filled pen (One-Press (R) patient controlled injector)
Artg Id: 321410
Artg Name: TREMFYA guselkumab (rch) 100 mg solution for injection pre-filled pen (One-Press (R) patient controlled injector)
Sponsor: Janssen-Cilag Pty Ltd
Company Detail Path: /organization/janssen-cilag-pty-ltd
Artg Date: 2020-05-13
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/e696186060f003ccba67be9a43b2b501.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/5e12b42981f7a9bd576f8a75fc34df40.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

7984cdd1bb71a8e5

Type

Standard