TGA Approval

SOLIRIS eculizumab (rmc) 300 mg/30 mL concentrated solution for intravenous infusion vial (138885)

ARTG ID

138885

ARTG Name

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

Sponsor

Alexion Pharmaceuticals Australasia Pty Ltd

ARTG Date

March 20, 2009

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

ALEXION PHARMACEUTICALS AUSTRALASIA PTY LTD

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-CMI-02955-3

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-02947-3

Ingredient Name

Eculizumab

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SOLIRIS eculizumab (rmc) 300 mg/30 mL concentrated solution for intravenous infusion vial (138885) - TGA 批准文号 | MedPath