THROMBOTROL-VF antithrombin III 1000IU powder for injection vial with diluent vial, CSL Behring Australia, CON-375
Product name
THROMBOTROL-VF antithrombin III 1000IU powder for injection vial with diluent vial
Sponsor name
CSL Behring Australia
Consent start
Consent no.
CON-375
Standard
Subparagraph 10(3)(a)(ii) of 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 product listed in this letter, that is
THROMBOTROL-VF antithrombin III 1000IU powder for injection vial with
diluent vial, 66736
Therapeutic product type
Prescription medicines