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

Leflunomide 10 mg film-coated tablets

European Regulatory Affairs t/a IvowenPA23156/001/001

Main Information

Trade NameLeflunomide 10 mg film-coated tablets
Active SubstancesLeflunomide
Dosage FormFilm-coated tablet
Licence HolderEuropean Regulatory Affairs t/a Ivowen
Licence NumberPA23156/001/001

Group Information

ATC CodeL04AA Selective immunosuppressants
L04AA13 leflunomide


License statusAuthorised
Licence Issued12/08/2011
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 Summary of Product Characteristics, section 4.2)
Marketing StatusNot marketed


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available

Educational Materials - HCP

HCP - Contact MAH for Educational Materials

Educational Materials - Patient

Patient - Contact MAH for Educational Materials
« Back