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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1667235
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Name of medicinal product:
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ATSIMUTIN
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Active substances:
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ATC code:
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L04AX01
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Dosage form:
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film-coated tablet
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Route of administration:
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oral use
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Strengh:
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25mg
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Amount in package:
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50TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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Indication:
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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.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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 (last updated May 23, 2022)
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Package information leaflet (PIL):
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EST (last updated July 30, 2021)
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Labelling:
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(last updated June 29, 2020)
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Bausch Health Ireland Limited
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Marketing authorization number:
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891615
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Marketing authorization issued on:
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November 11, 2015
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Mutual recognition
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Reference price:
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Under reference price:
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Reference price of daily dose:
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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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