Approvals/TGA/ANDEMBRY garadacimab 200 mg solution for injection pre-filled syringe with needle safety device

Approved

STANDARD

ANDEMBRY garadacimab 200 mg solution for injection pre-filled syringe with needle safety device

CSL Behring (Australia) Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 50b4c170a6e417b7
Product Name: ANDEMBRY garadacimab 200 mg solution for injection pre-filled syringe with needle safety device
Artg Id: 428253
Artg Name: ANDEMBRY garadacimab 200 mg solution for injection in pre-filled syringe with needle safety device
Sponsor: CSL Behring (Australia) Pty Ltd
Company Detail Path: /organization/csl-behring-australia-pty-ltd
Artg Date: 2025-01-14
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Product Information: https://medical-cdn.nocode.com/drug_tga/1927422de44f4bab57c289c05ce8ae07.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

50b4c170a6e417b7

Type

Standard