Is Mepolizumab 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 Mepolizumab, including Nucala (100 mg/ml, Solution for injection, SAR 4709.35); Nucala (40-0.4 mg/ml, Solution for injection in pre-filled syringe, SAR 1883.75).

Is Mepolizumab approved by the US FDA?

Drugs@FDA lists 2 application product lines for Mepolizumab, including NUCALA (Prescription); NUCALA (Prescription).

Is Mepolizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Mepolizumab: Nucala.

Are there safety signals or safety updates for Mepolizumab?

EMA PRAC: 3 entries; US FDA: 2 entries (latest 2025-09-04).

Active substance

Mepolizumab

SFDA 4
US FDA 2
EMA 2
Health Canada 3
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Nucala	100 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 4709.35	Biological · Prescription	Glaxo Saudi Arabia Ltd	Valid
Nucala	100 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 4709.35	Biological · Prescription	Glaxo Saudi Arabia Ltd	Valid
Nucala	40-0.4 mg/ml	Solution for injection in pre-filled syringe · Subcutaneous use	1 Pre-filled syringe	SAR 1883.75	Biological · Prescription	Glaxo Saudi Arabia Ltd.	Valid
NUCALA 100 mg POWDER FOR SOLUTION FOR INJECTION	100 mg	powder for solution for injection · Subcutaneous use	1 Vial	SAR 4284.65	Biological · Prescription	Glaxo Saudi Arabia Ltd	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

SINUSITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
NUCALA	100MG	injectable · subcutaneous lyophilized power	GLAXOSMITHKLINE LLC	Prescription	4 Nov 2015
NUCALA	100MG/ML	injectable · subcutaneous	GLAXOSMITHKLINE	Prescription	6 Jun 2019

EMA European Union — centrally authorised medicines

Nucala GlaxoSmithKline Trading Services Limited · Authorised · authorised 1 Dec 2015 · ATC R03DX09

Therapeutic indication (EMA)

Severe eosinophilic asthma Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older . Chronic rhinosinusitis with nasal polyps (CRSwNP) Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. Eosinophilic granulomatosis with polyangiitis (EGPA) Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Hypereosinophilic syndrome (HES) Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.

Bosatria Glaxo Group Limited · Application withdrawn

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NUCALA	02492989	100 MG / ML	SOLUTION · SUBCUTANEOUS	GLAXOSMITHKLINE INC
NUCALA	02492997	100 MG / ML	SOLUTION · SUBCUTANEOUS	GLAXOSMITHKLINE INC
NUCALA	02530821	40 MG / 0.4 ML	SOLUTION · SUBCUTANEOUS	GLAXOSMITHKLINE INC

Safety signals and safety-related labeling changes

EMA PRAC 4 Sep 2025 PRAC signal: Alopecia
Action for MAH: update of the product information: No
US FDA 6 Aug 2025 NUCALA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 May 2025 NUCALA — 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 May 2023 PRAC signal: Arthralgia
Action for MAH: update of the product information: No
EMA PRAC 31 Oct 2018 PRAC signal: Hypertensive crisis and hypertension
Action for MAH: update of the product information: No

All safety entries for mepolizumab →

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.