Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1212781
Name of medicinal product: ARAVA
Active substances:
Leflunomide
Estonian, English, Latin
ATC code: L04AA13
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 20mg
Amount in package: 50TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: October 12, 2009
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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