Is Moroctocog alfa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Moroctocog alfa, including XYNTHA 1000 I.U. POWDER FOR SOLUTION FOR INJECTION (1000 IU, Powder and solvent for solution for injection, SAR 1662.80); XYNTHA 2000 I.U. POWDER FOR SOLUTION FOR INJECTION (2000 IU, Powder and solvent for solution for injection, SAR 3325.60); XYNTHA 250 I.U. POWDER FOR SOLUTION FOR INJECTION (250 IU, Powder and solvent for solution for injection, SAR 415.85); XYNTHA 500 I.U. POWDER FOR SOLUTION FOR INJECTION (500 IU, Powder and solvent for solution for injection, SAR 831.65).

Is Moroctocog alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Moroctocog alfa: ReFacto AF.

Are there safety signals or safety updates for Moroctocog alfa?

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

Active substance

Moroctocog alfa

SFDA 4
EMA 1
Health Canada 6
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
XYNTHA 1000 I.U. POWDER FOR SOLUTION FOR INJECTION	1000 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 1662.80	Biological · Prescription	WYETH	Valid
XYNTHA 2000 I.U. POWDER FOR SOLUTION FOR INJECTION	2000 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 3325.60	Biological · Prescription	WYETH	Valid
XYNTHA 250 I.U. POWDER FOR SOLUTION FOR INJECTION	250 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 415.85	Biological · Prescription	WYETH	Valid
XYNTHA 500 I.U. POWDER FOR SOLUTION FOR INJECTION	500 IU	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 831.65	Biological · Prescription	WYETH	Valid

Indications — CHI Daman Drug Formulary

HEMOPHILIA A

EMA European Union — centrally authorised medicines

ReFacto AF Pfizer Europe MA EEIG · Authorised · authorised 13 Apr 1999 · ATC B02BD02

Therapeutic indication (EMA)

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency). ReFacto AF is appropriate for use in adults and children of all ages, including newborns. ReFacto AF does not contain von-Willebrand factor, and hence is not indicated in von-Willebrand's disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
XYNTHA	02309483	250 UNIT / VIAL	KIT; POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
XYNTHA	02309491	500 UNIT / VIAL	POWDER FOR SOLUTION; KIT · INTRAVENOUS	PFIZER CANADA ULC
XYNTHA SOLOFUSE	02374064	500 UNIT / SYR	POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
XYNTHA SOLOFUSE	02374072	1000 UNIT / SYR	POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
XYNTHA SOLOFUSE	02374080	2000 UNIT / SYR	POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
XYNTHA SOLOFUSE	02374099	3000 UNIT / SYR	POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC

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 moroctocog 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.