TGA Approval

QARZIBA dinutuximab beta 4.5 mg/mL concentrate for solution for infusion, 20 mg/4.5 mL vial (321016)

ARTG ID

321016

ARTG Name

QARZIBA dinutuximab beta 4.5 mg/mL concentrate for solution for infusion, 20 mg/4.5 mL vial

Sponsor

Recordati Rare Diseases Australia Pty Ltd

ARTG Date

April 2, 2020

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

RECORDATI RARE DISEASES AUSTRALIA PTY. LTD.

https://medical-cdn.nocode.com/drug_tga/3f0015e21d9978b26d327bbcf0d690e5.pdf

https://medical-cdn.nocode.com/drug_tga/490c31e5e3bf099ce43b2ba243a41153.pdf

Ingredient Name

dinutuximab beta

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QARZIBA dinutuximab beta 4.5 mg/mL concentrate for solution for infusion, 20 mg/4.5 mL vial (321016) - TGA 批准文号 | MedPath