SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
| Azathioprine QO | 50 mg | Tablet · Oral use | 100 Bottle | SAR 96.80 | Generic · Prescription | Qomel Co | Valid |
| IMURAN | 50 mg | Tablet · Oral use | 100 Blister | SAR 101.90 | Generic · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Valid |
| AZAMUN | 50 mg | Tablet · Oral use | 100 Tablet Container | SAR 92.70 | NCE · Prescription | BAYER SCHERING PHARMA | Withdrawn by MAH · Not Marketed |
| AZAPRIN | 50 mg | Tablet · Oral use | 100 Tablet Container | SAR 87.20 | Generic · Prescription | KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES | Suspended · Not Marketed |
| IMURAN | 50 mg | Tablet · Oral use | 100 Tablet Container | SAR 101.90 | Generic · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |
| IMURAN 50MG VIAL | 50 mg | Solution for injection · Intravenous use | 1 Vial | SAR 55.45 | NCE · Prescription | GLAXOSMITHKLINE (GSK) | Withdrawn by regulatory authority · Not Marketed |
| IMURAN 50MG VIAL | 50 mg | Solution for injection · Intravenous use | 1 Vial | SAR 54.85 | NCE · Prescription | ASPEN PHARMA TRADING LIMITED (APTL) | Withdrawn by MAH · Not Marketed |
| IMURAN 50MG VIAL | 50 mg | Solution for injection · Intravenous use | 1 Vial | SAR 54.85 | NCE · Prescription | ASPEN | Withdrawn by MAH · Not Marketed |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)
| Product | Strength | Form · route | Applicant | Status | First approved |
| IMURAN | 50MG | tablet · oral | LEGACY | Prescription | 20 Mar 1968 |
| AZATHIOPRINE SODIUM | EQ 100MG BASE/VIAL | injectable · injection | HIKMA PHARMS | Prescription | 31 Mar 1995 |
| AZATHIOPRINE | 50MG; 75MG; 100MG | tablet · oral | AMNEAL | Prescription | 16 Feb 1996 |
| AZASAN | 50MG; 25MG; 75MG; 100MG | tablet · oral | AAIPHARMA LLC | Prescription | 7 Jun 1999 |
| AZATHIOPRINE | 50MG | tablet · oral | RISING | Prescription | 13 Dec 1999 |
| AZATHIOPRINE | 50MG; 25MG; 75MG; 100MG | tablet · oral | ZYDUS PHARMS USA | Prescription | 15 Mar 2007 |
| AZATHIOPRINE | 25MG; 50MG; 75MG; 100MG | tablet · oral | ALKEM LABS LTD | Prescription | 27 Mar 2020 |
| IMURAN | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | LEGACY | Discontinued | 20 Mar 1968 |
| IMURAN | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | CASPER PHARMA LLC | Discontinued | 19 Jul 1974 |
| AZATHIOPRINE | EQ 100MG BASE/VIAL | injectable · injection | QUAD PHARMS | Discontinued | |
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)
| Brand | DIN | Strength | Form · route | Company |
| APO-AZATHIOPRINE | 02242907 | 50 MG | TABLET · ORAL | APOTEX INC |
| IMURAN | 00004596 | 50 MG | TABLET · ORAL | ASPEN PHARMACARE CANADA INC. |
| TEVA-AZATHIOPRINE | 02236819 | 50 MG | TABLET · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
| US NADAC | AZATHIOPRINE 100 MG TABLET | $3.31459 | per EA | 23 Sep 2026 |
| US NADAC | AZATHIOPRINE 50 MG TABLET | $0.12428 | per EA | 23 Sep 2026 |
| US NADAC | AZATHIOPRINE 75 MG TABLET | $7.65661 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Azathioprine 10mg/ml oral suspension sugar free | £250.00 | 200 ml | 1 Oct 2026 |
| NHS Drug Tariff | Azathioprine 25mg tablets | £1.30 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Azathioprine 50mg tablets | £1.74 | 56 tablet | 1 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)
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.