TGA Approval

XEMBIFY normal immunoglobulin 10 g/50 mL (20%) solution for subcutaneous injection vial (380406)

ARTG ID

380406

ARTG Name

XEMBIFY normal immunoglobulin 10 g/50 mL (20%) solution for subcutaneous injection vial

Sponsor

Grifols Australia Pty Ltd

ARTG Date

June 30, 2022

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

Grifols Australia Pty Ltd.

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022-CMI-01658-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2022-PI-01660-1

Ingredient Name

human immunoglobulin G

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XEMBIFY normal immunoglobulin 10 g/50 mL (20%) solution for subcutaneous injection vial (380406) - TGA 批准文号 | MedPath