BIOSTATE human coagulation factor VIII 1000IU/ von Willebrand factor 2400IU powder for injection vial with diluent vial, CSL Behring, CON-1249
Product name
BIOSTATE human coagulation factor VIII 1000IU/ von Willebrand factor 2400IU powder for injection vial with diluent vial
Sponsor name
CSL Behring
Consent start
Consent no.
CON-1249
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.
Therapeutic product type
Prescription medicines