Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1667303
Name of medicinal product: ATSIMUTIN
Active substances:
Estonian, English, Latin
ATC code: L04AX01
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 50mg
Amount in package: 56TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). Azathioprine 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 used as an immunosuppressant antimetabolite either alone, or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. Therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids. Azathioprine is indicated either alone or in combination with corticosteroids and/or other drugs and procedures in severe cases of the following diseases, in patients who are intolerant to steroids or who are dependent on steroids and in whom the therapeutic response is inadequate despite treatment with high doses of steroids: – severe active rheumatoid arthritis that cannot be kept under control by less toxic agents (diseasemodifying anti-rheumatic drugs, DMARDs) – severe or moderately severe inflammatory intestinal diseases (Crohn’s disease or ulcerative colitis) – systemic lupus erythematosus – dermatomyositis and polymyositis – auto-immune chronic active hepatitis – polyarteritis nodosa – auto-immune haemolytic anaemia – chronic refractory idiopathic thrombocytopenic purpura.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated May 23, 2022)
Package information leaflet (PIL): EST  (last updated July 30, 2021)
Labelling:  (last updated June 29, 2020)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Bausch Health Ireland Limited 
Marketing authorization number: 891715 
Marketing authorization issued on: November 11, 2015 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 20, 2022
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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