Approvals/TGA/SOLIRIS eculizumab (rmc) 300 mg/30 mL concentrated solution for intravenous infusion vial

Approved

STANDARD

SOLIRIS eculizumab (rmc) 300 mg/30 mL concentrated solution for intravenous infusion vial

Approval Id: 97d963480d3d15aa
Product Name: SOLIRIS eculizumab (rmc) 300 mg/30 mL concentrated solution for intravenous infusion vial
Artg Id: 138885
Artg Name: SOLIRIS eculizumab (rmc) 300 mg/30 mL concentrated solution for intravenous infusion vial
Sponsor: Alexion Pharmaceuticals Australasia Pty Ltd
Company Detail Path: /organization/alexion-pharmaceuticals-australasia-pty-ltd
Artg Date: 2009-03-20
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-CMI-02955-3
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-02947-3

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 30, 2025

Approval ID

97d963480d3d15aa

Type

Standard