Regulatory PathRegulatory requirements compared

Active substance

Upadacitinib

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Rinvoq15 mgProlonged-release tablet · Oral use30 BottleSAR 4685.40NCE · PrescriptionAbbVie IncValid
Rinvoq30 mgProlonged-release tablet · Oral use30 BottleSAR 5655.50NCE · PrescriptionABBVIE Deutschland GmbHValid
Rinvoq45 mgProlonged-release tablet · Oral use28 BottleSAR 7538.00NCE · PrescriptionABBVIE Deutschland GmbHValid
Indications — CHI Daman Drug Formulary

ANKYLOSING SPONDYLITIS; CROHN'S DISEASE; ECZEMA; PSORIATIC ARTHRITIS; RHEUMATOID ARITHRITIS; ULCERATIVE COLITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
RINVOQ15MG; 30MG; 45MGtablet, extended release · oralABBVIEPrescription16 Aug 2019
RINVOQ LQ1MG/MLsolution · oralABBVIEPrescription26 Apr 2024

EMA European Union — centrally authorised medicines

Rinvoq AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 16 Dec 2019 · ATC L04AA44

Therapeutic indication (EMA)

Rheumatoid arthritis Rinvoq is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Rinvoq may be used as monotherapy or in combination with methotrexate. Psoriatic arthritis Rinvoq 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 DMARDs. Rinvoq may be used as monotherapy or in combination with methotrexate. Polyarticular juvenile idiopathic arthritis Rinvoq is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [RF+] or negative [RF-], extended oligoarticular), in patients 2 years of age and older who have responded inadequately to, or who are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with methotrexate. Axial spondyloarthritis Non-radiographic axial spondyloarthritis (nr-axSpA) Rinvoq is indicated for the treatment of active non-radiographic axial spondyloarthritis in adult patients 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). Ankylosing spondylitis (AS, radiographic axial spondyloarthritis) Rinvoq is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy. Giant cell arteritis Rinvoq is indicated for the treatment of giant cell arteritis in adult patients. Atopic dermatitis Rinvoq 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. Alopecia areata Rinvoq is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Vitiligo Rinvoq is indicated for the treatment of non-segmental vitiligo in adults and adolescents 12 years and older who are candidates for systemic therapy. Ulcerative colitis Rinvoq is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. Crohn’s disease Rinvoq is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
RINVOQ0249515515 MGTABLET (EXTENDED-RELEASE) · ORALABBVIE CORPORATION
RINVOQ0252089330 MGTABLET (EXTENDED-RELEASE) · ORALABBVIE CORPORATION
RINVOQ0253972145 MGTABLET (EXTENDED-RELEASE) · ORALABBVIE CORPORATION

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACRINVOQ ER 15 MG TABLET$229.30897per EA23 Sep 2026
US NADACRINVOQ ER 30 MG TABLET$229.2939per EA23 Sep 2026
US NADACRINVOQ ER 45 MG TABLET$459.6225per EA23 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 30 Jun 2026 RINVOQ — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 30 Jun 2026 RINVOQ LQ — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for upadacitinib →

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.