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SOLIRIS eculizumab (rmc) 300 mg/30 mL concentrated solution for intravenous infusion vial - TGA Drug Approval Details
Approvals
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TGA
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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
Alexion Pharmaceuticals Australasia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
69f606e299909249
Company
Alexion Pharmaceuticals Australasia Pty Ltd
Type
Standard
Approval Details
Approval Id
69f606e299909249
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
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
69f606e299909249
Type
Standard
Back to TGA Approvals