This is a summary of the European public assessment report (EPAR) for Kovaltry. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Kovaltry. For practical information about using Kovaltry, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.
Therapeutic Area (MeSH)
ATC Code
B02BD02
ATC Item
coagulation factor VIII
Pharmacotherapeutic Group
Antihemorrhagics
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| octocog alfa | N/A | Antihemophilic factor, human recombinant |
| Octocog alfa | N/A | Antihemophilic factor, human recombinant |
EMA Name
Kovaltry
Medicine Name
Kovaltry
Aliases
N/ANo risk management plan link.