Approvals/TGA/ELFABRIO pegunigalsidase alfa 20 mg/10 mL concentrated injection vial

Approved

STANDARD

ELFABRIO pegunigalsidase alfa 20 mg/10 mL concentrated injection vial

Chiesi Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 7c987774009b8b4d
Product Name: ELFABRIO pegunigalsidase alfa 20 mg/10 mL concentrated injection vial
Artg Id: 446710
Artg Name: ELFABRIO pegunigalsidase alfa 20 mg/10 mL concentrated injection vial
Sponsor: Chiesi Australia Pty Ltd
Company Detail Path: /organization/chiesi-australia-pty-ltd
Artg Date: 2025-05-26
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Product Information: https://medical-cdn.nocode.com/drug_tga/0c1b6d3d29eca2b14e1ab9bc66ea4fa5.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

7c987774009b8b4d

Type

Standard