KOVALTRY Powder and solvent for solution for injection Ref.[8651] Active ingredients: Octocog alfa

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Bayer AG, 51368, Leverkusen, Germany

Product name and form

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

Powder and solvent for solution for injection.

Powder: solid, white to slightly yellow.

Solvent: water for injections, a clear solution.

Qualitative and quantitative composition

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
Histidine
Glycine
Sodium chloride
Calcium chloride dihydrate
Polysorbate 80
Acetic acid, glacial (for pH adjustment)

Solvent:

Water for injections

Pack sizes and marketing

Each single package of Kovaltry contains:

  • one vial with powder (10 mL clear glass type 1 vial with grey halogenobutyl rubber blend stopper and aluminium seal)
  • one pre-filled syringe with 2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and 3000 IU) solvent (clear glass cylinder type 1 with grey bromobutyl rubber blend stopper)
  • syringe plunger rod
  • vial adapter
  • one venipuncture set

Pack sizes:

  • 1 single pack.
  • 1 multipack with 30 single packs.

Not all pack sizes may be marketed.

Marketing authorization holder

Bayer AG, 51368, Leverkusen, Germany

Marketing authorization dates and numbers

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

Drugs

Drug Countries
KOVALTRY Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey

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