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 medac

medac Gesellschaft für klinische Spezialpräparate mbHEU/1/10/637/010-012

Main Information

Trade NameLeflunomide medac
Active SubstancesLeflunomide
Dosage FormFilm-coated tablet
Licence Holdermedac Gesellschaft für klinische Spezialpräparate mbH
Licence NumberEU/1/10/637/010-012

Group Information

ATC CodeL04AA Selective immunosuppressants
L04AA13 leflunomide


License statusAuthorised
Licence Issued
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 StatusUnknown


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