Approvals/TGA/REPLAGAL agalsidase alfa ghu 3.5mg/3.5mL concentrated injection vial

Approved

STANDARD

REPLAGAL agalsidase alfa ghu 3.5mg/3.5mL concentrated injection vial

Takeda Pharmaceuticals Australia Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 4c600c271ecc17fb
Product Name: REPLAGAL agalsidase alfa ghu 3.5mg/3.5mL concentrated injection vial
Artg Id: 82818
Artg Name: REPLAGAL agalsidase alfa ghu 3.5mg/3.5mL concentrated injection vial
Sponsor: Takeda Pharmaceuticals Australia Pty Ltd
Company Detail Path: /organization/takeda-pharmaceuticals-australia-pty-ltd
Artg Date: 2002-05-17
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/b8fabab8f7cafbcdf9b22002e83222b7.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/ad79b84f1d8c029b2c9bde09bdfd7c34.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 28, 2025

Approval ID

4c600c271ecc17fb

Type

Standard