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ULTOMIRIS ravulizumab rch 1100 mg in 11 mL (100 mg/mL) concentrated solution for injection by intravenous infusion vial - TGA Drug Approval Details
Approvals
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TGA
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ULTOMIRIS ravulizumab rch 1100 mg in 11 mL (100 mg/mL) concentrated solution for injection by intravenous infusion vial
Approved
STANDARD
ULTOMIRIS ravulizumab rch 1100 mg in 11 mL (100 mg/mL) concentrated solution for injection by intravenous infusion vial
Alexion Pharmaceuticals Australasia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
d841aca0337b1ccf
Company
Alexion Pharmaceuticals Australasia Pty Ltd
Type
Standard
Approval Details
Approval Id
d841aca0337b1ccf
Product Name
ULTOMIRIS ravulizumab rch 1100 mg in 11 mL (100 mg/mL) concentrated solution for injection by intravenous infusion vial
Artg Id
336710
Artg Name
ULTOMIRIS ravulizumab rch 1100 mg in 11 mL (100 mg/mL) concentrated solution for injection by intravenous infusion vial
Sponsor
Alexion Pharmaceuticals Australasia Pty Ltd
Company Detail Path
/organization/alexion-pharmaceuticals-australasia-pty-ltd
Artg Date
2021-03-23
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/03673dee6a630d3b5fe10624f5268b1e.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/9f7ff1e1863095aa340de0da9ff657ec.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
d841aca0337b1ccf
Type
Standard
Back to TGA Approvals