Is Human coagulation factor viii registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Human coagulation factor viii, including ADVATE 1000 IU (1000 IU, Powder and solvent for solution for injection, SAR 2504.70); ADVATE 250 IU (250 IU, Powder and solvent for solution for injection, SAR 618.20); ADVATE 500 IU (500 IU, Powder and solvent for solution for injection, SAR 1236.45); Kovaltry (250 IU, Powder and solvent for solution for injection, SAR 455.15); Kovaltry (500 IU, Powder and solvent for solution for injection, SAR 876.40).

Are there safety signals or safety updates for Human coagulation factor viii?

EMA PRAC: 2 entries (latest 2018-02-08).

Active substance

Human coagulation factor viii

SFDA 15
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ADVATE 1000 IU	1000 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 2504.70	Biological · Prescription	Takeda Manufacturing Austria AG	Valid
ADVATE 250 IU	250 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 618.20	Biological · Prescription	Takeda Manufacturing Austria AG	Valid
ADVATE 500 IU	500 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 1236.45	Biological · Prescription	Takeda Manufacturing Austria AG	Valid
Kovaltry	250 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 455.15	Biological · Prescription	BAYER AG	Valid
Kovaltry	500 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 876.40	Biological · Prescription	BAYER AG	Valid
Kovaltry	1000 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 1779.40	Biological · Prescription	BAYER AG	Valid
OCTANATE 1000 I.U - ML	1000 IU	Powder and solvent for solution for injection · Parenteral use	1 Vial	SAR 1777.15	Biological · Prescription	OCTAPHARMA	Valid
OCTANATE 250IU VIAL	250 IU	Powder and solvent for solution for injection · Parenteral use	1 Vial	SAR 444.25	Biological · Prescription	OCTAPHARMA	Valid
OCTANATE 500IU VIAL	500 IU	Powder and solvent for solution for injection · Parenteral use	1 Vial	SAR 888.60	Biological · Prescription	OCTAPHARMA	Valid
ALPHANATE 250 IU VIAL+5ML DILUENT	250 IU	Solution · Parenteral use	1 Vial	SAR 421.05	Biological · Prescription	GRIFOLS BIOLOGICALS LLC	Withdrawn by MAH · Not Marketed
DRIED FACTOR VIII TYPE 8Y 25IU-ML VIAL	500 IU	Powder and solvent for solution for infusion · Parenteral use	1 Vial	SAR 517.30	Biological · Prescription	BIO-PRODUCT LAB	Withdrawn by MAH · Not Marketed
DRIED FACTOR VIII TYPE 8Y 25IU-ML VIAL	250 IU	Powder and solvent for solution for injection · Parenteral use	1 Vial	SAR 258.65	Biological · Prescription	BIO-PRODUCT LAB	Withdrawn by MAH · Not Marketed
RECOMBINATE 1000IU VIAL	1000 IU	Powder and solvent for solution for injection · Parenteral use	1 Vial	SAR 2504.70	Biological · Prescription	BAXTER	Withdrawn by MAH · Not Marketed
RECOMBINATE 250IU VIAL	250 IU	Powder and solvent for solution for injection · Parenteral use	1 Vial	SAR 668.40	Biological · Prescription	BAXTER	Withdrawn by MAH · Not Marketed
RECOMBINATE 500IU VIAL	500 IU	Powder and solvent for solution for injection · Parenteral use	1 Vial	SAR 1312.90	Biological · Prescription	BAXTER	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

HEMOPHILIA A, ACQUIRED HEMOPHILIA

Safety signals and safety-related labeling changes

EMA PRAC 8 Feb 2018 PRAC signal: Inhibitor development in previously untreated patients (PUPs) with haemophilia A treated with plasma-derived vs recombinant coagulation factor VIII concentrates
Action for MAH: update of the product information: No
EMA PRAC 8 Jul 2016 PRAC signal: Inhibitor development in previously untreated patients (PUPs) with haemophilia A treated with plasma-derived vs recombinant coagulation factor VIII concentrates
Action for MAH: update of the product information: No

All safety entries for human coagulation factor viii →

Combinations containing Human coagulation factor viii

Human coagulation factor viii + human von willebrand factor

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.