Balfaxar
Balfaxar ingredients
| Active ingredient | Strength |
|---|---|
| Coagulation Factor Ix Human | 25.5 [iU]/mL |
| Prothrombin | 26 [iU]/mL |
| Coagulation Factor Vii Human | 16.5 [iU]/mL |
| Coagulation Factor X Human | 24 [iU]/mL |
| Protein C | 22 [iU]/mL |
| Protein S Human | 22 [iU]/mL |
What Balfaxar is used for
The FDA lists the approved uses on the official label (below). In the EU, human coagulation factor X is approved as Coagadex for:
Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. Coagadex is indicated in all age groups.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Balfaxar
- Generic name
- Prothrombin complex concentrate (human)
- Made by
- Octapharma USA Inc
- Forms
- Powder, For Solution
- Given
- Intravenous
- Drug class
- Anti-coagulant, Blood Coagulation Factor, Human Blood Coagulation Factor
- FDA approval
- Biologic licence (BLA) BLA125776
- On the US market since
- 2023
Official information
- MedlinePlus drug information (search for Prothrombin complex concentrate (human))
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Balfaxar?
Balfaxar (Prothrombin complex concentrate (human)) is a specialist medicine made by Octapharma USA Inc, approved by the US FDA.
What are the ingredients of Balfaxar?
Balfaxar contains Coagulation Factor Ix Human (25.5 [iU]/mL); Prothrombin (26 [iU]/mL); Coagulation Factor Vii Human (16.5 [iU]/mL); Coagulation Factor X Human (24 [iU]/mL); Protein C (22 [iU]/mL); Protein S Human (22 [iU]/mL).
Is Balfaxar approved in Europe?
The same active substance is approved in the EU as Coagadex.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
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