Cevenfacta (eptacog beta (activated))
- Region
- 🇪🇺 EU
- Active substance
- eptacog beta (activated)
- Company
- Laboratoire Francais du Fractionnement et des Biotechnologies
- Status
- Authorised
- Therapeutic area
- Hemophilia A; Hemophilia B
- CHMP opinion
- Thu 19 May 2022
- EU approval
- Fri 15 Jul 2022
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005655
- ATC
- B02BD08
- Official record
- www.ema.europa.eu
Indication
CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups: in patients with congenital haemophilia with high-responding inhibitors to coagulation factors VIII or IX (i.e. ?5 Bethesda Units (BU)); in patients with congenital haemophilia with low titre inhibitors (BU <5), but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.