Is Emicizumab 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 Emicizumab, including HEMLIBRA 150 MG/ML SOLUTION FOR INJECTION (150 mg/ml, Solution for injection, SAR 44604.40); HEMLIBRA 30 MG/ML SOLUTION FOR INJECTION (30 mg/ml, Solution for injection, SAR 8920.85).

Is Emicizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Emicizumab, including HEMLIBRA (Prescription).

Is Emicizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Emicizumab: Hemlibra.

Is Emicizumab on the WHO Model List of Essential Medicines?

Yes — 10.2. Medicines affecting coagulation (core list): Haemophilia A.

Are there safety signals or safety updates for Emicizumab?

EMA PRAC: 1 entry; US FDA: 1 entry (latest 2025-07-08).

Active substance

Emicizumab

SFDA 4
US FDA 1
EMA 1
Health Canada 6
WHO EML 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
HEMLIBRA 150 MG/ML SOLUTION FOR INJECTION	150 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 44604.40	Biological · Prescription	ROCHE	Valid
HEMLIBRA 150 MG/ML SOLUTION FOR INJECTION	150 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 31222.85	Biological · Prescription	ROCHE	Valid
HEMLIBRA 150 MG/ML SOLUTION FOR INJECTION	150 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 17841.45	Biological · Prescription	ROCHE	Valid
HEMLIBRA 30 MG/ML SOLUTION FOR INJECTION	30 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 8920.85	Biological · Prescription	ROCHE	Valid

Indications — CHI Daman Drug Formulary

HEMOPHILIA A

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
HEMLIBRA	30MG/ML; 60MG/0.4ML; 105MG/0.7ML; 150MG	injectable · injection	GENENTECH INC	Prescription	16 Nov 2017

EMA European Union — centrally authorised medicines

Hemlibra Roche Registration Limited · Authorised · authorised 23 Feb 2018 · ATC B02BX06

Therapeutic indication (EMA)

Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency): with factor VIII inhibitors without factor VIII inhibitors who have: severe disease (FVIII < 1%) moderate disease (FVIII ? 1% and ? 5%) with severe bleeding phenotype. Hemlibra can be used in all age groups.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
HEMLIBRA	02479621	30 MG / 1 ML	SOLUTION · SUBCUTANEOUS	HOFFMANN-LA ROCHE LIMITED
HEMLIBRA	02479648	60 MG / 0.4 ML	SOLUTION · SUBCUTANEOUS	HOFFMANN-LA ROCHE LIMITED
HEMLIBRA	02479656	105 MG / 0.7 ML	SOLUTION · SUBCUTANEOUS	HOFFMANN-LA ROCHE LIMITED
HEMLIBRA	02479664	150 MG / ML	SOLUTION · SUBCUTANEOUS	HOFFMANN-LA ROCHE LIMITED
HEMLIBRA	02556049	12 MG / 0.4 ML	SOLUTION · SUBCUTANEOUS	HOFFMANN-LA ROCHE LIMITED
HEMLIBRA	02556057	300 MG / 2 ML	SOLUTION · SUBCUTANEOUS	HOFFMANN-LA ROCHE LIMITED

WHO WHO Model List of Essential Medicines (2025)

10.2. Medicines affecting coagulation · core
Haemophilia A
Parenteral > General injections > SC: 12 mg per 0.4 mL in vial (EMLc); 30 mg per mL in mL vial (EMLc); 60 mg per 0.4 mL in vial; 105 mg per 0.7 mL in vial (EML); 150 mg per mL in vial (EML); 300 mg per 2 mL in vial (EML)

Safety signals and safety-related labeling changes

US FDA 8 Jul 2025 HEMLIBRA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 12 Apr 2018 PRAC signal: New information on the known risk of haemorrhagic events
Action for MAH: update of the product information: No

All safety entries for emicizumab →

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.