BIOSTATE human coagulation factor VIII 500IU / von Willebrand Factor 1200IU powder for injection vial with diluent vial, CSL Behring Australia, CON-376
Product name
BIOSTATE human coagulation factor VIII 500IU / von Willebrand Factor 1200IU powder for injection vial with diluent vial
Sponsor name
CSL Behring Australia
Consent start
Consent no.
CON-376
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
All excipients are listed on the currently approved 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
BIOSTATE human coagulation factor VIII 500IU/ von Willebrand factor 1200IU
powder for injection vial with diluent vial, 150648
BIOSTATE human coagulation factor VIII 1000IU/ von Willebrand factor
2400IU powder for injection vial with diluent vial, 150657
BIOSTATE human coagulation factor VIII 250IU / von Willebrand Factor 600IU
powder for injection vial with diluent vial, 73032
BIOSTATE human coagulation factor VIII 500IU / von Willebrand Factor
1200IU powder for injection vial with diluent vial, 79993
Therapeutic product type
Prescription medicines