The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail info@hpra.ie


ARAVA

20 Milligram Tablets

Sanofi-Aventis Deutschland GmbHEU/1/99/118/008

Main Information

Trade NameARAVA
Active SubstancesLEFLUNOMIDE
Strength20 Milligram
Dosage FormTablets
Licence HolderSanofi-Aventis Deutschland GmbH
Licence NumberEU/1/99/118/008

Group Information

ATC CodeL04AA13 leflunomide

Status

Authorised/WithdrawnAuthorised
Licence Issued02/09/1999
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Marketing Status

Documents

Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website

Educational Materials - HCP

Educational Materials - Patient

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