PROTHROMBINEX-VF human prothrombin complex powder for injection vial and diluent vial, CSL Behring Australia, CON-351
Product name
PROTHROMBINEX-VF human prothrombin complex powder for injection vial and diluent vial
Sponsor name
CSL Behring Australia
Consent start
Consent no.
CON-351
Standard
Subparagraph 10(3)(a)(ii) and subsection 9(5) of the Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines (TGO No. 91)
Non-compliance with standard
The product vial label does not contain the name and quantity of each excipient
in the medicineThe name of the active ingredient(s) and the quantity or
proportion of active ingredient(s) are not displayed in a text size of not less
than 3.0 millimetres
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.
The name of the active ingredients and their quantity 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 PROTHROMBINEX-VF human prothrombin complex
powder for injection vial and diluent vial [AUSTR 124381]
Therapeutic product type
Prescription medicines