TGA Approval

SARCLISA isatuximab 100 mg/5 mL concentrated injection vial (319086)

ARTG ID

319086

ARTG Name

SARCLISA isatuximab 100 mg/5 mL concentrated injection vial

Sponsor

Sanofi-Aventis Australia Pty Ltd

ARTG Date

May 6, 2020

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

SANOFI-AVENTIS AUSTRALIA PTY LTD

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2020-CMI-01681-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2020-PI-01680-1

Ingredient Name

isatuximab

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SARCLISA isatuximab 100 mg/5 mL concentrated injection vial (319086) - TGA 批准文号 | MedPath