Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Bayer AG, 51368, Leverkusen, Germany
Kovaltry 250 IU powder and solvent for solution for injection.
Kovaltry 500 IU powder and solvent for solution for injection.
Kovaltry 1000 IU powder and solvent for solution for injection.
Kovaltry 2000 IU powder and solvent for solution for injection.
Kovaltry 3000 IU powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
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Powder and solvent for solution for injection. Powder: solid, white to slightly yellow. Solvent: water for injections, a clear solution. |
Kovaltry 250 IU powder and solvent for solution for injection: One mL Kovaltry 250 IU contains approximately 100 IU (250 IU/2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Kovaltry 500 IU powder and solvent for solution for injection: One mL Kovaltry 500 IU contains approximately 200 IU (500 IU/2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Kovaltry 1000 IU powder and solvent for solution for injection: One mL Kovaltry 1000 IU contains approximately 400 IU (1000 IU/2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Kovaltry 2000 IU powder and solvent for solution for injection: One mL Kovaltry 2000 IU contains approximately 400 IU (2000 IU/5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Kovaltry 3000 IU powder and solvent for solution for injection: One mL Kovaltry 3000 IU contains approximately 600 IU (3000 IU/5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Kovaltry is approximately 4000 IU/mg protein.
Octocog alfa (Full length recombinant human coagulation factor VIII (rDNA)) is a purified protein that has 2,332 amino acids. It is produced by recombinant DNA technology in baby hamster kidney cells (BHK) into which the human factor VIII gene has been introduced. Kovaltry is prepared without the addition of any human or animal derived protein in the cell culture process, purification or final formulation.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Octocog alfa |
Octocog alfa (Full length recombinant human coagulation factor VIII (rDNA)) is a purified protein that has 2,332 amino acids. It is produced by recombinant DNA technology in baby hamster kidney cells (BHK) into which the human factor VIII gene has been introduced. |
| List of Excipients |
|---|
|
Powder: Sucrose Solvent: Water for injections |
Each single package of Kovaltry contains:
Pack sizes:
Not all pack sizes may be marketed.
Bayer AG, 51368, Leverkusen, Germany
EU/1/15/1076/002 1 x (Kovaltry 250 IU – solvent (2.5 mL); pre-filled syringe (3 mL))
EU/1/15/1076/012 – 1 x (Kovaltry 250 IU – solvent (2.5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/004 – 1 x (Kovaltry 500 IU – solvent (2.5 mL); pre-filled syringe (3 mL))
EU/1/15/1076/014 – 1 x (Kovaltry 500 IU – solvent (2.5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/006 – 1 x (Kovaltry 1000 IU – solvent (2.5 mL); pre-filled syringe (3 mL))
EU/1/15/1076/016 – 1 x (Kovaltry 1000 IU – solvent (2.5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/008 – 1 x (Kovaltry 2000 IU – solvent (5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/010 – 1 x (Kovaltry 3000 IU – solvent (5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/017 30 x (Kovaltry 250 IU – solvent (2.5 mL); pre-filled syringe (3 mL))
EU/1/15/1076/018 – 30 x (Kovaltry 250 IU – solvent (2.5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/019 – 30 x (Kovaltry 500 IU – solvent (2.5 mL); pre-filled syringe (3 mL))
EU/1/15/1076/020 – 30 x (Kovaltry 500 IU – solvent (2.5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/021 – 30 x (Kovaltry 1000 IU – solvent (2.5 mL); pre-filled syringe (3 mL))
EU/1/15/1076/022 – 30 x (Kovaltry 1000 IU – solvent (2.5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/023 – 30 x (Kovaltry 2000 IU – solvent (5 mL); pre-filled syringe (5 mL))
EU/1/15/1076/024 – 30 x (Kovaltry 3000 IU – solvent (5 mL); pre-filled syringe (5 mL))
Date of first authorisation: 18 February 2016
| Drug | Countries | |
|---|---|---|
| KOVALTRY | Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey |
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