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REPSO

20 Milligram Film Coated Tablet

Teva B.V.EU/1/11/674/006-010

Main Information

Trade NameREPSO
Active SubstancesLEFLUNOMIDE
Strength20 Milligram
Dosage FormFilm Coated Tablet
Licence HolderTeva B.V.
Licence NumberEU/1/11/674/006-010

Group Information

ATC CodeL04AA13 leflunomide

Status

Authorised/WithdrawnAuthorised
Licence Issued14/03/2011
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 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
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