BERIPLEX AU human prothrombin complex 500 IU powder for injection vial, CSL Behring Australia Pty Ltd, CON-1251
Product name
BERIPLEX AU human prothrombin complex 500 IU powder for injection vial
Sponsor name
CSL Behring Australia Pty Ltd
Consent start
Consent no.
CON-1251
Standard
Part 2 Section 10(9) and Schedule 1 Item 8(b), Item 8(c);
Part 2 Section 10(4) Schedule 1 Item 10(d);
Part 2 Section 10(4) Schedule 1 Item 10(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Part 2 Section 10(4) Schedule 1 Item 10(d);
Part 2 Section 10(4) Schedule 1 Item 10(c) of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
The products will not comply with: - the requirement of indefinite geographical
deferral for variant Creutzfeldt-Jakob disease (vCJD) risk, applicable to blood
and plasma donors having spent a cumulative length of time of 6 months or more
in the UK between 1980 and 1996 or receiving a transfusion or injection of blood
or blood components while in the UK at any time on or after 1 January 1980. -
Donor selection criteria for deferral following body piercing - where single-use
equipment is used, and it is less than 4 months since the procedure and where
the person tests negative for HCV using NAT - Donor selection criteria for
deferral following tattoo - in that people who have a tattoo performed at a
licensed/registered tattoo parlour or cosmetic clinic in Australia can be
accepted as a donor for plasma for fractionation only with no deferral period
from the time of the last tattoo procedure.
Conditions imposed
That the sponsor continues to monitor the literature and informs the TGA of any
new evidence that substantively alters the estimated risks, such that they
become unacceptable.
Therapeutic product type
Prescription medicines