Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1667325
Name of medicinal product: ATSIMUTIN
Active substances:
Azathioprine
Estonian, English, Latin
ATC code: L04AX01
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 50mg
Amount in package: 100TK
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: November 30, 2022
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 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  01.10.2022     Yes      No      
75  01.10.2022     Yes  K50-K51; K73-K74  Gastroenteroloog, Pediaater  No      
75  01.10.2022     Yes  L20-L20  Dermatoveneroloog  No      
75  01.10.2022     Yes  M30-M35; M05-M08; M45-M46  Pediaater, Reumatoloog  No      
75  01.10.2022     Yes  L12-L12; L13.0-L13.0; L10-L10  Pediaater, Dermatoveneroloog, Allergoloog-immunoloog  No      
75  01.10.2022     Yes  L40-L40  Pediaater, Dermatoveneroloog  No      
75  01.10.2022     Yes  N00-N08  Pediaater, Nefroloog  No      
90  01.10.2022     Yes  K50-K51; K73-K74  Pediaater, Gastroenteroloog  No      
90  01.10.2022     Yes  N00-N08  Nefroloog, Pediaater  No  from 63 years   
90  01.10.2022     Yes  N00-N08  Pediaater, Nefroloog  No      
90  01.10.2022     Yes  L12-L12; L13.0-L13.0; L10-L10  Pediaater, Dermatoveneroloog, Allergoloog-immunoloog  No  from 63 years   
90  01.10.2022     Yes  K50-K51; K73-K74  Gastroenteroloog, Pediaater  No      
90  01.10.2022     Yes  L40-L40  Dermatoveneroloog, Pediaater  No      
90  01.10.2022     Yes  M30-M35; M05-M08; M45-M46  Reumatoloog, Pediaater  No  4 years - 17 years   
90  01.10.2022     Yes  L20-L20  Dermatoveneroloog  No      
90  01.10.2022     Yes  M30-M35; M05-M08; M45-M46  Pediaater, Reumatoloog  No      
90  01.10.2022     Yes  N00-N08  Nefroloog, Pediaater  No      
90  01.10.2022     Yes  K50-K51; K73-K74  Gastroenteroloog, Pediaater  No  4 years - 17 years   
90  01.10.2022     Yes  L40-L40  Pediaater, Dermatoveneroloog  No  from 63 years   
90  01.10.2022     Yes  L12-L12; L13.0-L13.0; L10-L10  Pediaater, Allergoloog-immunoloog, Dermatoveneroloog  No      
90  01.10.2022     Yes  L12-L12; L13.0-L13.0; L10-L10  Allergoloog-immunoloog, Pediaater, Dermatoveneroloog  No  4 years - 17 years   
90  01.10.2022     Yes  L20-L20  Dermatoveneroloog  No  from 63 years   
90  01.10.2022     Yes  L40-L40  Pediaater, Dermatoveneroloog  No  4 years - 17 years   
90  01.10.2022     Yes  K50-K51; K73-K74  Pediaater, Gastroenteroloog  No  from 63 years   
90  01.10.2022     Yes  L40-L40  Pediaater, Dermatoveneroloog  No      
90  01.10.2022     Yes  M30-M35; M05-M08; M45-M46  Reumatoloog, Pediaater  No      
90  01.10.2022     Yes  M30-M35; M05-M08; M45-M46  Pediaater, Reumatoloog  No  from 63 years   
90  01.10.2022     Yes  L20-L20  Dermatoveneroloog  No      
90  01.10.2022     Yes  N00-N08  Pediaater, Nefroloog  No  4 years - 17 years   
90  01.10.2022     Yes  L12-L12; L13.0-L13.0; L10-L10  Allergoloog-immunoloog, Dermatoveneroloog, Pediaater  No      
90  01.10.2022     Yes  L20-L20  Dermatoveneroloog  No  4 years - 17 years   
100  01.10.2022     Yes  K50-K51; K73-K74  Pediaater, Gastroenteroloog  No  until 4 years   
100  01.10.2022     Yes  Z94-Z94; T86-T86    No  until 4 years   
100  01.10.2022     Yes  Z94-Z94; T86-T86    No      
100  01.10.2022     Yes      No  until 4 years   
100  01.10.2022     Yes  L20-L20  Dermatoveneroloog  No  until 4 years   
100  01.10.2022     Yes  G70-G70  Neuroloog, Pediaater  Yes  until 4 years   
100  01.10.2022     Yes  M30-M35; M05-M08; M45-M46  Pediaater, Reumatoloog  No  until 4 years   
100  01.10.2022     Yes  L12-L12; L13.0-L13.0; L10-L10  Allergoloog-immunoloog, Pediaater, Dermatoveneroloog  No  until 4 years   
100  01.10.2022     Yes  N00-N08  Nefroloog, Pediaater  No  until 4 years   
100  01.10.2022     Yes  L40-L40  Dermatoveneroloog, Pediaater  No  until 4 years   
100  01.10.2022     Yes  G70-G70  Pediaater, Neuroloog  Yes      
Reference price: 19,67 EUR 
Under reference price: Yes 
Reference price of daily dose: 0,59 EUR 
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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