Is Ixekizumab 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 Ixekizumab, including TALTZ 80 mg/ml Injection (80 mg/ml, Solution for injection in pre-filled pen, SAR 4259.15).

Is Ixekizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Ixekizumab, including TALTZ (Prescription).

Is Ixekizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ixekizumab: Taltz.

Are there safety signals or safety updates for Ixekizumab?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2026-05-07).

Active substance

Ixekizumab

SFDA 1
US FDA 1
EMA 1
Health Canada 2
US price lines 3
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
TALTZ 80 mg/ml Injection	80 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	1 Automatic Injection Device	SAR 4259.15	Biological · Prescription	Eli Lilly and Company	Valid

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
TALTZ	80MG/ML	injectable · injection	ELI LILLY AND CO	Prescription	22 Mar 2016

EMA European Union — centrally authorised medicines

Taltz Eli Lilly and Company (Ireland) Limited · Authorised · authorised 25 Apr 2016 · ATC L04AC13

Therapeutic indication (EMA)

Plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.Paediatric plaque psoriasisTaltz is indicated for the treatment of moderate to severe plaque psoriasis in children from the age of 6 years and with a body weight of at least 25 kg and adolescents who are candidates for systemic therapy.Psoriatic arthritisTaltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies. Axial spondyloarthritis Ankylosing spondylitis (radiographic axial spondyloarthritis)Taltz is indicated for the treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. Non-radiographic axial spondyloarthritis Taltz is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).Juvenile idiopathic arthritis (JIA)Juvenile psoriatic arthritis (JPsA)Taltz, alone or in combination with methotrexate, is indicated for the treatment of active JPsA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.Enthesitis-related arthritis (ERA)Taltz, alone or in combination with methotrexate, is indicated for the treatment of active ERA in patients 6 years of age and older and with a body weight of at least 25 kg, who have had an inadequate response to, or who are intolerant of, conventional therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TALTZ	02455102	80 MG / ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
TALTZ	02455110	80 MG / ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TALTZ 80 MG/ML AUTOINJECTOR	$7370.71514	per ML	23 Sep 2026
US NADAC	TALTZ 80 MG/ML AUTOINJECTOR (2-PACK)	$7435.87075	per ML	1 Jan 2026
US NADAC	TALTZ 80 MG/ML AUTOINJECTOR (3-PACK)	$7388.222	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

EMA PRAC 7 May 2026 PRAC signal: Behcet’s syndrome
Action for MAH: update of the product information: No
EMA PRAC 13 Mar 2025 PRAC signal: Demyelinating disorders
Action for MAH: update of the product information: No
EMA PRAC 31 Oct 2024 PRAC signal: Demyelinating disorders
Action for MAH: update of the product information: No
US FDA 20 Aug 2024 TALTZ — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ixekizumab →

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.