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DOTAREM gadoteric acid 279.32mg/mL injection 10mL vial - TGA Drug Approval Details
Approvals
/
TGA
/
DOTAREM gadoteric acid 279.32mg/mL injection 10mL vial
Approved
STANDARD
DOTAREM gadoteric acid 279.32mg/mL injection 10mL vial
Guerbet Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
081b339f7a02b57d
Company
Guerbet Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
081b339f7a02b57d
Product Name
DOTAREM gadoteric acid 279.32mg/mL injection 10mL vial
Artg Id
76925
Artg Name
DOTAREM gadoteric acid 279.32mg/mL injection 10mL vial
Sponsor
Guerbet Australia Pty Ltd
Company Detail Path
/organization/guerbet-australia-pty-ltd
Artg Date
2000-12-11
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
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
081b339f7a02b57d
Type
Standard
Back to TGA Approvals