This is a summary of the European public assessment report (EPAR) for ReFacto AF. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ReFacto AF.
Therapeutic Indication
### Therapeutic indication Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). ReFacto AF is appropriate for use in adults and children of all ages, including newborns. ReFacto AF does not contain von-Willebrand factor, and hence is not indicated in von-Willebrand's disease.
Therapeutic Area (MeSH)
ATC Code
B02BD02
ATC Item
coagulation factor VIII
Pharmacotherapeutic Group
Antihemorrhagics
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| moroctocog alfa | N/A | Moroctocog alfa |
EMA Name
ReFacto AF
Medicine Name
ReFacto AF
Aliases
N/ANo risk management plan link.
