MONOFIX-VF human coagulation factor IX 500IU powder for injection vial and diluent vial, CSL Behring Australia, CON-373
Product name
MONOFIX-VF human coagulation factor IX 500IU powder for injection vial and diluent vial
Sponsor name
CSL Behring Australia
ARTG
Consent start
Consent no.
CON-373
Standard
Subparagraph 10(3)(a)(ii) in the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The products' vial label does not contain the name and quantity of each
excipient in the medicine.
Conditions imposed
The excipients are listed on the carton and in the Product Information
(PI) and Consumer Medicine Information (CMI), which are both supplied in the
carton.
This exemption only applies to the products listed in this letter, that is
MONOFIX-VF human coagulation factor IX 500IU powder for injection vial
and 5 mL diluent vial, 101710
MONOFIX-VF human coagulation factor IX 1000IU powder for injection vial
and 10 mL diluent vial, 101711
MONOFIX-VF human coagulation factor IX 500IU powder for injection vial
and diluent vial, 66066
Therapeutic product type
Prescription medicines