Is Risankizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Risankizumab, including SKYRIZI 75 mg (75 mg, Solution for injection in pre-filled syringe, SAR 13774.25); Skyrizi (150 mg/ml, Solution for injection in cartridge, SAR 11102.95); Skyrizi 150 mg (150 mg, Solution for injection, SAR 13774.25); Skyrizi 360 mg per 2.4 ml (150 mg/ml, Solution for injection in cartridge, SAR 13323.90); Skyrizi 600 mg per 10 ml (60 mg/ml, Solution for infusion, SAR 11103.25).

Is Risankizumab approved by the US FDA?

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

Is Risankizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Risankizumab: Skyrizi.

Are there safety signals or safety updates for Risankizumab?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2026-06-26).

Active substance

Risankizumab

SFDA 5
US FDA 2
EMA 1
Health Canada 5
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
SKYRIZI 75 mg	75 mg	Solution for injection in pre-filled syringe · Subcutaneous use	2 Pre-filled syringe	SAR 13774.25	Biological · Prescription	ABBVIE Deutschland GmbH	Valid
Skyrizi	150 mg/ml	Solution for injection in cartridge · Subcutaneous use	1 Cartridge	SAR 11102.95	Biological · Prescription	AbbVie Inc	Valid
Skyrizi 150 mg	150 mg	Solution for injection · Subcutaneous use	1 Pre-filled pen	SAR 13774.25	Biological · Prescription	ABBVIE Deutschland GmbH	Valid
Skyrizi 360 mg per 2.4 ml	150 mg/ml	Solution for injection in cartridge · Subcutaneous use	1 Cartridge	SAR 13323.90	Biological · Prescription	AbbVie Inc	Valid
Skyrizi 600 mg per 10 ml	60 mg/ml	Solution for infusion · Intravenous use	1 Vial	SAR 11103.25	Biological · Prescription	AbbVie Inc	Valid

Indications — CHI Daman Drug Formulary

CROHN'S DISEASE; PSORIATIC ARTHRITIS; ULCERATIVE COLITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
SKYRIZI	75MG/0.83ML; 150MG/ML	injectable · injection	ABBVIE INC	Prescription	23 Apr 2019
SKYRIZI	600MG/VIAL	injectable · intravenous	ABBVIE INC	Prescription	16 Jun 2022

EMA European Union — centrally authorised medicines

Skyrizi AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 26 Apr 2019 · ATC L04AC18

Therapeutic indication (EMA)

Adult plaque psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Paediatric plaque psoriasis Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy. Psoriatic Arthritis Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). Crohn’s disease Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. Ulcerative colitis Skyrizi is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
SKYRIZI	02519283	150 MG / 1 ML	SOLUTION · SUBCUTANEOUS	ABBVIE CORPORATION
SKYRIZI	02519291	150 MG / 1 ML	SOLUTION · SUBCUTANEOUS	ABBVIE CORPORATION
SKYRIZI	02532093	360 MG / 2.4 ML	SOLUTION · SUBCUTANEOUS	ABBVIE CORPORATION
SKYRIZI	02532107	60 MG / ML	SOLUTION · INTRAVENOUS	ABBVIE CORPORATION
SKYRIZI	02552507	180 MG / 1.2 ML	SOLUTION · SUBCUTANEOUS	ABBVIE CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	SKYRIZI 150 MG/ML PEN	$22774.36091	per ML	23 Sep 2026
US NADAC	SKYRIZI 150 MG/ML SYRINGE	$22887.43857	per ML	23 Sep 2026
US NADAC	SKYRIZI 360 MG/2.4 ML ON-BODY	$9572.665	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 26 Jun 2026 SKYRIZI — 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 26 Jun 2026 SKYRIZI — 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 Feb 2026 PRAC signal: Pemphigoid
Action for MAH: update of the product information: No
EMA PRAC 4 Sep 2025 PRAC signal: Pemphigoid
Action for MAH: update of the product information: No

All safety entries for risankizumab →

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.