BIOSTATE human coagulation factor VIII 250IU / von Willebrand Factor 600IU powder for injection vial with diluent vial, CSL Behring, CON-1249
Product name
BIOSTATE human coagulation factor VIII 250IU / von Willebrand Factor 600IU powder for injection vial with diluent vial
Sponsor name
CSL Behring
Consent start
Consent no.
CON-1249
Duration
The consent is effective from 5 April 2024 until 1 October 2031.
Standard
Part 2 Subsection 10(4) Schedule 1 Item 10 (c) – Period of ineligibility (a) or (b) or (c). of Therapeutic Goods (Standard for Human Cell and Tissue Products - Donor Selection Requirements) (TGO 108) Order 2021
Non-compliance with standard
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.
Import, Supply, &/or Export
supply
Therapeutic product type
Prescription medicines