Takeda Manufacturing Austria AG (batch release; manufacturing, in-process control, batch quality control and stability testing of the medicinal product; labelling, primary and secondary packaging of the medicinal product and diluent; batch quality control and stability testing (Sterility and Bacterial Endotoxins))

The drug is used for the treatment of bleeding and its prevention before surgery in cases of acquired clotting factor deficiency (e.g., due to the intake of vitamin K antagonists or their overdose), as well as in congenital clotting factor deficiency if specialized products are unavailable.

Dosage form: powder and solvent for injection solution

ATC: B02BD01