Octaplas

STN: 125416
Proper Name: Pooled Plasma (Human), Solvent/Detergent Treated
Tradename: Octaplas
Manufacturer: Octapharma Pharmazeutika Produktionsges.m.b.H.
Indication:
Octaplas is a solvent/detergent (S/D) treated, pooled human plasma indicated for

• Replacement of multiple coagulation factors in patients with acquired deficiencies
  • Due to liver disease
  • Undergoing cardiac surgery or liver transplantation
• Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP)

Product Information

• Package Insert-Octaplas

Supporting Documents

• April 18, 2024 Approval Letter - Octaplas
• Clinical Memorandum - Octaplas
• February 25, 2021 Approval Letter - Octaplas
• March 29, 2019 Approval Letter - Octaplas
• Clinical Review (BLA 125416/140) - Octaplas
• Approval History, Letters, Review, and Related Documents - Octaplas
• Supporting Documents older than three years - Octaplas