Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ARAVA
Active substances:
Leflunomide
Estonian, English, Latin
ATC code: L04AK01
Dosage form: film-coated tablet
Strength: 20mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: Leflunomide is indicated for the treatment of adult patients with: - active rheumatoid arthritis as a "disease-modifying antirheumatic drug" (DMARD), - active psoriatic arthritis,. Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit/risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the switching.
Safety features: Yes
Marketing authorization holder: Sanofi-Aventis Deutschland GmbH 
Marketing authorization number: EU/1/99/118 
Marketing authorization issued on: April 26, 2000 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1009932  ARAVA  film-coated tablet  20mg 30TK  Prescription  90% 100% 75% 50%  37,50  05.07.2024     
1071830  ARAVA  film-coated tablet  20mg 100TK  Prescription           
1212781  ARAVA  film-coated tablet  20mg 50TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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