Is Secukinumab 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 Secukinumab, including COSENTYX 150 mg/ml solution for injection in pre-filled pen (150 mg/ml, Solution for injection, SAR 2114.55); COSENTYX 75 mg/0.5 ml Solution for injection in pre-filled syringe (75 mg, Solution for injection, SAR 1008.35); Cosentyx 300 mg per 2 ml Solution for injection in pre-filled pen (300 mg, Solution for injection, SAR 4033.45).

Is Secukinumab approved by the US FDA?

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

Is Secukinumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Secukinumab: Cosentyx.

Are there safety signals or safety updates for Secukinumab?

EMA PRAC: 5 entries; US FDA: 2 entries (latest 2026-04-17).

Active substance

Secukinumab

SFDA 5
US FDA 2
EMA 1
Health Canada 5
US price lines 2
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
COSENTYX 150 mg/ml solution for injection in pre-filled pen	150 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 2114.55	NCE · Prescription	NOVARTIS PHARMA AG	Valid
COSENTYX 75 mg/0.5 ml Solution for injection in pre-filled syringe	75 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 1008.35	Biological · Prescription	NOVARTIS PHARMA AG	Valid
Cosentyx 300 mg per 2 ml Solution for injection in pre-filled pen	300 mg	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 4033.45	Biological · Prescription	NOVARTIS PHARMA AG	Valid
COSENTYX 150 mg/ml solution for injection in pre-filled syringe	150 mg/ml	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 2114.55	NCE · Prescription	NOVARTIS PHARMA AG	Withdrawn by MAH · Not Marketed
Cosentyx 300 mg per 2 ml Solution for injection in pre-filled syringe	300 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 4033.45	Biological · Prescription	NOVARTIS PHARMA AG	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANKYLOSING SPONDYLITIS; PSORIASIS; PSORIATIC ARTHRITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
COSENTYX	150MG/ML	injectable · injection	NOVARTIS PHARMS CORP	Prescription	21 Jan 2015
COSENTYX	150MG	injectable · injection	NOVARTIS PHARMS CORP	Prescription	6 Oct 2023

EMA European Union — centrally authorised medicines

Cosentyx Novartis Europharm Limited · Authorised · authorised 14 Jan 2015 · ATC L04AC10

Therapeutic indication (EMA)

Plaque psoriasis Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. Hidradenitis suppurativa (HS) Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy. Psoriatic arthritis Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate. Axial spondyloarthritis (axSpA) Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis (nr-axSpA) Cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (NSAIDs). Juvenile idiopathic arthritis (JIA) Enthesitis-related arthritis (ERA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Juvenile psoriatic arthritis (JPsA) Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
COSENTYX	02438070	150 MG / ML	SOLUTION · SUBCUTANEOUS	NOVARTIS PHARMACEUTICALS CANADA INC
COSENTYX	02525569	75 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	NOVARTIS PHARMACEUTICALS CANADA INC
COSENTYX	02529653	300 MG / 2 ML	SOLUTION · SUBCUTANEOUS	NOVARTIS PHARMACEUTICALS CANADA INC
COSENTYX	02529661	300 MG / 2 ML	SOLUTION · SUBCUTANEOUS	NOVARTIS PHARMACEUTICALS CANADA INC
COSENTYX	02547724	150 MG / ML	SOLUTION · SUBCUTANEOUS	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	COSENTYX (150 MG/ML) 300 MG DOSE-2 SYRINGES	$3924.35313	per ML	23 Sep 2026
US NADAC	COSENTYX 150 MG/ML SYRINGE	$7879.81111	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 17 Apr 2026 COSENTYX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 17 Apr 2026 COSENTYX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 6 May 2021 PRAC signal: Henoch-Schonlein purpura
Action for MAH: update of the product information: Yes
EMA PRAC 14 Jan 2021 PRAC signal: Facial paralysis
Action for MAH: update of the product information: No
EMA PRAC 14 Jan 2021 PRAC signal: Henoch-Schonlein purpura
Action for MAH: update of the product information: No
EMA PRAC 14 Jun 2019 PRAC signal: Dermatitis exfoliative generalised
Action for MAH: update of the product information: Yes
EMA PRAC 14 Feb 2019 PRAC signal: Dermatitis exfoliative generalised
Action for MAH: update of the product information: No

All safety entries for secukinumab →

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.