Regulatory PathRegulatory requirements compared

Active substance

Certolizumab pegol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
CIMZIA 200 mg Solution for Injection200 mgSolution for injection · Subcutaneous use2 Pre-filled syringeSAR 2839.40Biological · PrescriptionU.C.B.Valid
Indications — CHI Daman Drug Formulary

ANKYLOSING SPONDYLITIS; CROHN'S DISEASE; PSORIASIS; PSORIATIC ARTHRITIS; RHEUMATOID ARITHRITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
CIMZIA200MGinjectable · injectionUCB INCPrescription22 Apr 2008

EMA European Union — centrally authorised medicines

Cimzia UCB Pharma · Authorised · authorised 1 Oct 2009 · ATC L04AB05

Therapeutic indication (EMA)

Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for: the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including MTX, has been inadequate. Cimzia can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs. Cimzia has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function, when given in combination with MTX. Axial spondyloarthritis Cimzia is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising: Ankylosing spondylitis (AS) Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Axial spondyloarthritis without radiographic evidence of AS Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated C reactive protein (CRP) and /or magnetic resonance imaging (MRI), who have had an inadequate response to, or are intolerant to NSAIDs. Psoriatic arthritis Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Cimzia UCB Pharma SA · Refused · ATC L04AB05

Therapeutic indication (EMA)

Cimzia, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARD) including methotrexate, has been inadequate.Cimzia can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.Cimzia has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CIMZIA02331675200 MG / MLSOLUTION · SUBCUTANEOUSUCB CANADA INC
CIMZIA02465574200 MG / MLSOLUTION · SUBCUTANEOUSUCB CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACCIMZIA 2X200 MG/ML SYRINGE KIT$6094.025per 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.

WHO WHO Model List of Essential Medicines (2025)

  • 8.1. Immunomodulators for non-malignant disease · complementary
    Therapeutic equivalent to adalimumab for Axial spondyloarthritis; Therapeutic equivalent to adalimumab for Crohn disease site; Therapeutic equivalent to adalimumab for Rheumatoid arthritis
  • 29.3. Medicines for juvenile joint diseases · complementary
    Therapeutic equivalent to adalimumab for Juvenile idiopathic arthritis
  • 13.4. Dermatological medicines > Medicines affecting skin differentiation and proliferation · complementary
    Therapeutic equivalent to adalimumab for Psoriasis of unspecified type

Safety signals and safety-related labeling changes

All safety entries for certolizumab pegol →

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.