SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| CEVENFACTA | 1 mg | Powder and solvent for solution for injection · Intravenous use | 1 Vial | SAR 3168.00 | Biological · Prescription | Laboratoire français du Fractionnement et des Biotechnologies | Valid |
| CEVENFACTA | 2 mg | Powder and solvent for solution for injection · Intravenous use | 1 Vial | SAR 6348.50 | Biological · Prescription | Laboratoire français du Fractionnement et des Biotechnologies | Valid |
| CEVENFACTA | 5 mg | Powder and solvent for solution for injection · Intravenous use | 1 Vial | SAR 15842.65 | Biological · Prescription | Laboratoire français du Fractionnement et des Biotechnologies | Valid |
Indications — CHI Daman Drug Formulary
HEMOPHILIA A, HEMOPHILIA B, ACQUIRED HEMOPHILIA
EMA European Union — centrally authorised medicines
Cevenfacta Laboratoire Francais du Fractionnement et des Biotechnologies · Authorised · authorised 15 Jul 2022 · ATC B02BD08
Therapeutic indication (EMA)
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.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.