Approvals/TGA/MONOFIX-VF human coagulation factor IX 1000IU powder for injection vial and 10 mL diluent vial

Approved

STANDARD

MONOFIX-VF human coagulation factor IX 1000IU powder for injection vial and 10 mL diluent vial

CSL Behring (Australia) Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 94413e62250bbdf4
Product Name: MONOFIX-VF human coagulation factor IX 1000IU powder for injection vial and 10 mL diluent vial
Artg Id: 101711
Artg Name: MONOFIX-VF human coagulation factor IX 1000IU powder for injection vial and 10 mL diluent vial
Sponsor: CSL Behring (Australia) Pty Ltd
Company Detail Path: /organization/csl-behring-australia-pty-ltd
Artg Date: 2005-05-31
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: https://medical-cdn.nocode.com/drug_tga/a2c317fd515e375ea6f086b020cfe354.pdf
Product Information: https://medical-cdn.nocode.com/drug_tga/c8114dcbdfaa8f6beef60eb374c6b624.pdf

Approved

Agency

TGA

Country

🇦🇺

Approval Date

May 29, 2025

Approval ID

94413e62250bbdf4

Type

Standard