OCTAPLAS
STN: 125416
Proper Name: Pooled Plasma (Human), Solvent/Detergent Treated
Tradename: OCTAPLAS
Manufacturer: Octapharma Pharmazeutika Produktionsges.m.b.H.
Indication:
- (1) Replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease and in patients undergoing cardiac surgery or liver transplantation; and
- (2) plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).
Product Information
Supporting Documents
- October 1, 2024 Approval Letter - Octaplas
- 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