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Leflunomide Winthrop



Zentiva k.s.EU/1/09/604/5-9

Main Information

Trade NameLeflunomide Winthrop
Active SubstancesLeflunomide
Dosage FormFilm-coated tablet
Licence HolderZentiva k.s.
Licence NumberEU/1/09/604/5-9

Group Information

ATC CodeL04AA Selective immunosuppressants
L04AA13 leflunomide

Status

License statusAuthorised
Licence Issued08/01/2010
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

Documents

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