TGA Approval

VYLOY zolbetuximab 100 mg vial powder for concentrate for solution for infusion (428330)

ARTG ID

428330

ARTG Name

VYLOY zolbetuximab 100 mg vial powder for concentrate for solution for infusion

Sponsor

Astellas Pharma Australia Pty Ltd

ARTG Date

March 17, 2025

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

ASTELLAS PHARMA AUSTRALIA PTY LTD

https://medical-cdn.nocode.com/drug_tga/9261dbcb0188342185f817b1aad032a7.pdf

https://medical-cdn.nocode.com/drug_tga/c2dfe7cb8d4335b13ad2ca8fcb37ddc1.pdf

Ingredient Name

zolbetuximab

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VYLOY zolbetuximab 100 mg vial powder for concentrate for solution for infusion (428330) - TGA 批准文号 | MedPath