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apheresis recovered plasma , Australian Red Cross Lifeblood , CON-1348
Product name
apheresis recovered plasma
Sponsor name
Australian Red Cross Lifeblood
Consent start
Consent no.
CON-1348
Duration
The consent is effective from 9 April 2025 until 1 October 2031.
Standard
monograph 'Human plasma for fractionation' (0853) of European Pharmacopoeia
Non-compliance with standard
The product does not conform with the requirements of the European Pharmacopoeia
monograph Human plasma for fractionation (0853) in that the post-collection the
freezing time for apheresis plasma for fractionation has been changed from 24
hours to 72 hours, to allow apheresis plasma to be used when the freezing time
post-collection exceeds 24 hours.
Conditions imposed
A risk assessment determining that the change will have negligible impact of
plasma derived medicinal products has been conducted.
Import, Supply, &/or Export
supply
Therapeutic product type
Blood, tissues, and biologicals