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

Approved

STANDARD

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

Approval Id: 9d60dcaef16b9824
Product Name: QARZIBA dinutuximab beta 4.5 mg/mL concentrate for solution for infusion, 20 mg/4.5 mL vial
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
Company Detail Path: /organization/recordati-rare-diseases-australia-pty-ltd
Artg Date: 2020-04-02
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/3f0015e21d9978b26d327bbcf0d690e5.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/490c31e5e3bf099ce43b2ba243a41153.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

9d60dcaef16b9824

Type

Standard