Approvals/TGA/DOTAREM gadoteric acid 279.32mg/mL injection 10 mL pre-filled syringe

Approved

STANDARD

DOTAREM gadoteric acid 279.32mg/mL injection 10 mL pre-filled syringe

Guerbet Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 5509684cbf975bf5
Product Name: DOTAREM gadoteric acid 279.32mg/mL injection 10 mL pre-filled syringe
Artg Id: 160798
Artg Name: DOTAREM gadoteric acid 279.32mg/mL injection 10 mL pre-filled syringe
Sponsor: Guerbet Australia Pty Ltd
Company Detail Path: /organization/guerbet-australia-pty-ltd
Artg Date: 2010-08-26
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/55b2ac83ade1258d6edfa5234915fe22.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/f84b51923aa91d33f0c75f8a2405039b.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 29, 2025

Approval ID

5509684cbf975bf5

Type

Standard