OCTAPLAS LG solvent/detergent human plasma solution for injection bag 200 mL, Octapharma Australia Pty Ltd, CON-34
Product name
OCTAPLAS LG solvent/detergent human plasma solution for injection bag 200 mL
Sponsor name
Octapharma Australia Pty Ltd
Consent start
Consent no.
CON-34
Standard
European Pharmacopoeia monograph 1646 'Human Plasma pooled and treated for virus inactivation'.
Non-compliance with standard
The product does not meet the anti-Hepatitis A virus (HAV) antibody limit of ‰¥ 1
IU/ mL.
Conditions imposed
The Hepatitis A antibody levels of the product must be ‰¥ 0.3 IU/mL.
The sensitivity of the Hepatitis A virus nucleic acid test used on the
manufacturing pool is ‰¤13 IU/mL.
Therapeutic product type
Prescription medicines