Is Dupilumab 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 Dupilumab, including DUPIXENT 200 mg Solution for Injection in Pre-filled syringe (200 mg, Solution for injection, SAR 4637.75); Dupixent 200 mg Solution for injection in pre-filled pen (200 mg, Solution for injection, SAR 5408.60); Dupixent 300 mg Solution for injection in pre-filled pen (300 mg, Solution for injection, SAR 5408.60).

Is Dupilumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Dupilumab, including DUPIXENT (Prescription).

Is Dupilumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Dupilumab: Dupixent.

Are there safety signals or safety updates for Dupilumab?

EMA PRAC: 4 entries; US FDA: 1 entry; MHRA: 1 entry (latest 2026-04-22).

Active substance

Dupilumab

SFDA 4
US FDA 1
EMA 1
Health Canada 4
US price lines 4
Safety 6

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
DUPIXENT 200 mg Solution for Injection in Pre-filled syringe	200 mg	Solution for injection · Subcutaneous use	2 Pre-filled syringe	SAR 4637.75	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
Dupixent 200 mg Solution for injection in pre-filled pen	200 mg	Solution for injection · Subcutaneous use	2 Pre-filled pen	SAR 5408.60	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
Dupixent 300 mg Solution for injection in pre-filled pen	300 mg	Solution for injection · Subcutaneous use	2 Pre-filled pen	SAR 5408.60	Biological · Prescription	SANOFI AVENTIS GROUPE	Valid
DUPIXENT 300 mg Solution for Injection in Pre-filled syringe	300 mg	Solution for injection · Subcutaneous use	2 Pre-filled syringe	SAR 4637.75	Biological · Prescription	SANOFI AVENTIS GROUPE	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ASTHMA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)-PREVENTION OF EXACERBATIONS; ECZEMA; PEMPHIGOID; POLYCYTHEMIA VERA - PRURITUS; SINUSITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
DUPIXENT	150MG/ML	injectable · injection	REGENERON PHARMACEUTICALS	Prescription	28 Mar 2017

EMA European Union — centrally authorised medicines

Dupixent Sanofi Winthrop Industrie · Authorised · authorised 26 Sep 2017 · ATC D11AH05

Therapeutic indication (EMA)

Atopic dermatitis Adults and adolescents Dupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. Children 6 months to 11 years of age Dupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. Asthma Adults and adolescents Dupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Children 6 to 11 years of age Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment. Chronic rhinosinusitis with nasal polyposis (CRSwNP) Dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. Prurigo Nodularis (PN) Dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy. Eosinophilic esophagitis (EoE) Dupixent is indicated for the treatment of eosinophilic esophagitis in adults, adolescents and children aged 1 year and older, weighing at least 15 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. Chronic obstructive pulmonary disease (COPD) Dupixent is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate. Chronic Spontaneous Urticaria (CSU) Dupixent is indicated for the treatment of moderate to severe chronic spontaneous urticaria in adults, adolescents and children (2 years and above) patients with inadequate response to H1 antihistamines and who are naive to anti-IgE therapy for CSU.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DUPIXENT	02470365	300 MG / 2 ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
DUPIXENT	02492504	200 MG / 1.14 ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
DUPIXENT	02510049	300 MG / 2 ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC
DUPIXENT	02524252	200 MG / 1.14 ML	SOLUTION · SUBCUTANEOUS	SANOFI-AVENTIS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	DUPIXENT 200 MG/1.14 ML PEN	$1778.85887	per ML	23 Sep 2026
US NADAC	DUPIXENT 200 MG/1.14 ML SYRING	$1773.73509	per ML	23 Sep 2026
US NADAC	DUPIXENT 300 MG/2 ML PEN	$1009.5592	per ML	23 Sep 2026
US NADAC	DUPIXENT 300 MG/2 ML SYRINGE	$1010.59551	per ML	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 22 Apr 2026 DUPIXENT — 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 11 Jul 2024 PRAC signal: Thrombocytopenia
Action for MAH: update of the product information: No
EMA PRAC 7 Mar 2024 PRAC signal: Thrombocytopenia
Action for MAH: update of the product information: No
EMA PRAC 16 Mar 2023 PRAC signal: Weight decreased, abnormal loss of weight, cachexia, body mass index decreased
Action for MAH: update of the product information: No
MHRA 29 Nov 2022 Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management
Healthcare professionals prescribing dupilumab should be alert to the risks of ocular reactions. New onset or worsening ocular symptoms require prompt review. Referral for ophthalmological examination should be made as appropriate.
EMA PRAC 16 Jan 2020 PRAC signal: Corneal disorders
Action for MAH: update of the product information: No

All safety entries for dupilumab →

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.