This is a summary of the European Public Assessment Report (EPAR) for BeneFIX. 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 BeneFIX.
Therapeutic Indication
Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor\-IX deficiency).
Therapeutic Area (MeSH)
ATC Code
B02BD04
ATC Item
N/A
Pharmacotherapeutic Group
Antihemorrhagics
Active Substance (Summary)
INN / Common Names
EMA Name
BeneFIX
Medicine Name
BeneFIX
Aliases
N/ANo risk management plan link.
