Is Benralizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Benralizumab, including FASENRA Pen (30 mg/ml, Solution for injection, SAR 9386.85).

Is Benralizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Benralizumab, including FASENRA (Prescription).

Is Benralizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Benralizumab: Fasenra.

Are there safety signals or safety updates for Benralizumab?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2026-05-13).

Active substance

Benralizumab

SFDA 2
US FDA 1
EMA 1
Health Canada 2
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
FASENRA Pen	30 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 9386.85	Biological · Prescription	AstraZeneca AB	Valid
FASENRA 30MG/ML SOL. FOR INJECTION	30 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 9386.85	Biological · Prescription	AstraZeneca AB	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ASTHMA

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

Product	Strength	Form · route	Applicant	Status	First approved
FASENRA	30MG/ML	injectable · injection	ASTRAZENECA AB	Prescription	14 Nov 2017

EMA European Union — centrally authorised medicines

Fasenra AstraZeneca AB · Authorised · authorised 8 Jan 2018 · ATC R03DX10

Therapeutic indication (EMA)

AsthmaFasenra is indicated as an add on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long acting β agonists (see section 5.1).Eosinophilic granulomatosis with polyangiitis (EGPA) Fasenra is indicated as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis. Hypereosinophilic syndrome (HES) Fasenra is indicated as an add on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FASENRA	02473232	30 MG / ML	SOLUTION · SUBCUTANEOUS	ASTRAZENECA CANADA INC
FASENRA PEN	02496135	30 MG / ML	SOLUTION · SUBCUTANEOUS	ASTRAZENECA CANADA INC

Safety signals and safety-related labeling changes

US FDA 13 May 2026 FASENRA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Apr 2019 PRAC signal: Pneumonia
Action for MAH: update of the product information: No
EMA PRAC 29 Nov 2018 PRAC signal: Anaphylactic reaction
Action for MAH: update of the product information: No

All safety entries for benralizumab →

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.