Is Turoctocog alfa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Turoctocog alfa, including NOVOEIGHT 1000 IU Powder & Solvent For Solution For Injection (1000 IU, Powder and solvent for solution for injection, SAR 2295.90); NOVOEIGHT 250 IU Powder & Solvent For Solution For Injection (250 IU, Powder and solvent for solution for injection, SAR 574.00); NOVOEIGHT 500 IU Powder & Solvent For Solution For Injection (500 IU, Powder and solvent for solution for injection, SAR 1147.95).

Is Turoctocog alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Turoctocog alfa: NovoEight.

Are there safety signals or safety updates for Turoctocog alfa?

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

Active substance

Turoctocog alfa

SFDA 6
EMA 1
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
NOVOEIGHT 1000 IU Powder & Solvent For Solution For Injection	1000 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 2295.90	Biological · Prescription	NOVO NORDISK	Valid
NOVOEIGHT 250 IU Powder & Solvent For Solution For Injection	250 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 574.00	Biological · Prescription	NOVO NORDISK	Valid
NOVOEIGHT 500 IU Powder & Solvent For Solution For Injection	500 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 1147.95	Biological · Prescription	NOVO NORDISK	Valid
NOVOEIGHT 1500 IU Powder & Solvent For Solution For Injection	1500 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 3757.05	Biological · Prescription	NOVO NORDISK	Withdrawn by MAH · Not Marketed
NOVOEIGHT 2000 IU Powder & Solvent For Solution For Injection	2000 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 5009.40	Biological · Prescription	NOVO NORDISK	Withdrawn by MAH · Not Marketed
NOVOEIGHT 3000 IU Powder & Solvent For Solution For Injection	3000 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 7514.10	Biological · Prescription	NOVO NORDISK	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

HEMOPHILIA A

EMA European Union — centrally authorised medicines

NovoEight Novo Nordisk A/S · Authorised · authorised 13 Nov 2013 · ATC B02BD02

Therapeutic indication (EMA)

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Novoeight can be used for all age groups.

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 turoctocog alfa →

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.