TGA Approval

ELUCIREM gadopiclenol 3.64 mg/7.5 mL injection solution prefilled syringe (444270)

ARTG ID

444270

ARTG Name

ELUCIREM gadopiclenol 3.64 mg/7.5 mL injection solution prefilled syringe

Sponsor

Guerbet Australia Pty Ltd

ARTG Date

April 22, 2025

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

GUERBET AUSTRALIA PTY LTD

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2025-CMI-01523-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2025-PI-01522-1

Ingredient Name

gadopiclenol

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ELUCIREM gadopiclenol 3.64 mg/7.5 mL injection solution prefilled syringe (444270) - TGA 批准文号 | MedPath