Regulatory PathRegulatory requirements compared

Active substance

Azathioprine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Azathioprine QO50 mgTablet · Oral use100 BottleSAR 96.80Generic · PrescriptionQomel CoValid
IMURAN50 mgTablet · Oral use100 BlisterSAR 101.90Generic · PrescriptionASPEN PHARMA TRADING LIMITED (APTL)Valid
AZAMUN50 mgTablet · Oral use100 Tablet ContainerSAR 92.70NCE · PrescriptionBAYER SCHERING PHARMAWithdrawn by MAH · Not Marketed
AZAPRIN50 mgTablet · Oral use100 Tablet ContainerSAR 87.20Generic · PrescriptionKUWAIT SAUDI PHARMACEUTICAL INDUSTRIESSuspended · Not Marketed
IMURAN50 mgTablet · Oral use100 Tablet ContainerSAR 101.90Generic · PrescriptionASPENWithdrawn by MAH · Not Marketed
IMURAN 50MG VIAL50 mgSolution for injection · Intravenous use1 VialSAR 55.45NCE · PrescriptionGLAXOSMITHKLINE (GSK)Withdrawn by regulatory authority · Not Marketed
IMURAN 50MG VIAL50 mgSolution for injection · Intravenous use1 VialSAR 54.85NCE · PrescriptionASPEN PHARMA TRADING LIMITED (APTL)Withdrawn by MAH · Not Marketed
IMURAN 50MG VIAL50 mgSolution for injection · Intravenous use1 VialSAR 54.85NCE · PrescriptionASPENWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ACQUIRED HEMOPHILIA; AUTOIMMUNE HEPATITIS; CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY; CROHN'S DISEASE; ECZEMA; GLOMERULAR DISEASE; GRANULOMATOSIS WITH POLYANGIITIS AND MICROSCOPIC POLYANGIITIS; HYPERTHYROIDISM; IMMUNE THROMBOCYPTOPENIC PUPURA; LICHEN PLANUS; MULTIPLE SCLEROSIS; MYASTHENIA GRAVIS; MYOSITIS; NON-INFECTIOUS UVEITIS; PEMPHIGOID; PEMPHIGUS; PERIPHERAL SPONDYLOARTHRITIS ASSOCIATED WITH UVEITIS, NON INFECTIOUS; POLYCYTHEMIA VERA - PRURITUS; RENAL TRANSPLANT; SARCOIDOSIS; SJOGREN'S SYNDROME; SYSTEMIC LUPUS ERYTHEMATOSUS; THROMBOTIC THROMBOCYTOPENIC PURPURA; ULCERATIVE COLITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
IMURAN50MGtablet · oralLEGACYPrescription20 Mar 1968
AZATHIOPRINE SODIUMEQ 100MG BASE/VIALinjectable · injectionHIKMA PHARMSPrescription31 Mar 1995
AZATHIOPRINE50MG; 75MG; 100MGtablet · oralAMNEALPrescription16 Feb 1996
AZASAN50MG; 25MG; 75MG; 100MGtablet · oralAAIPHARMA LLCPrescription7 Jun 1999
AZATHIOPRINE50MGtablet · oralRISINGPrescription13 Dec 1999
AZATHIOPRINE50MG; 25MG; 75MG; 100MGtablet · oralZYDUS PHARMS USAPrescription15 Mar 2007
AZATHIOPRINE25MG; 50MG; 75MG; 100MGtablet · oralALKEM LABS LTDPrescription27 Mar 2020
IMURAN25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralLEGACYDiscontinued20 Mar 1968
IMURANEQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionCASPER PHARMA LLCDiscontinued19 Jul 1974
AZATHIOPRINEEQ 100MG BASE/VIALinjectable · injectionQUAD PHARMSDiscontinued

EMA European Union — centrally authorised medicines

Jayempi Lipomed GmbH · Authorised · authorised 21 Jun 2021 · ATC L04AX01

Therapeutic indication (EMA)

Jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. Azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). Jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. Jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases: severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – DMARDs) auto-immune hepatitis systemic lupus erythematosus dermatomyositis polyarteritis nodosa pemphigus vulgaris and bullous pemphigoid Behçet’s disease refractory auto-immune haemolytic anaemia, caused by warm IgG antibodies chronic refractory idiopathic thrombocytopenic purpura Jayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (IBD) (Crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. It is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3 Jayempi is indicated for the treatment of generalised myasthenia gravis. Depending on the severity of the disease, Jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-AZATHIOPRINE0224290750 MGTABLET · ORALAPOTEX INC
IMURAN0000459650 MGTABLET · ORALASPEN PHARMACARE CANADA INC.
TEVA-AZATHIOPRINE0223681950 MGTABLET · ORALTEVA CANADA LIMITED

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACAZATHIOPRINE 100 MG TABLET$3.31459per EA23 Sep 2026
US NADACAZATHIOPRINE 50 MG TABLET$0.12428per EA23 Sep 2026
US NADACAZATHIOPRINE 75 MG TABLET$7.65661per EA23 Sep 2026
NHS Drug TariffAzathioprine 10mg/ml oral suspension sugar free£250.00200 ml1 Oct 2026
NHS Drug TariffAzathioprine 25mg tablets£1.3028 tablet1 Oct 2026
NHS Drug TariffAzathioprine 50mg tablets£1.7456 tablet1 Oct 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)

  • 29.2. Disease-modifying anti-rheumatic drugs (DMARDs) · complementary
    Rheumatoid arthritis, serology unspecified; Psoriatic arthritis
    Oral > Solid > tablet: 50 mg (scored)
  • 8.1. Immunomodulators for non-malignant disease · complementary
    Failure or rejection of transplanted organs or tissues
    Parenteral > General injections > IV: 50 mg in vial powder for injection (as sodium salt); 100 mg in vial powder for injection (as sodium salt) (EMLc) | Oral > Liquid: 10 mg per mL (EMLc) | Oral > Solid > tablet: 25 mg; 50 mg (scored) (EMLc)

Safety signals and safety-related labeling changes

All safety entries for azathioprine →

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.