Leflunomide Zentiva (previously Leflunomide Winthrop)



This medicine is authorised for use in the European Union.


Leflunomide Zentiva is a medicine used to treat adults with active rheumatoid arthritis (an immune system disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints). The medicine contains the active substance leflunomide. 

This EPAR was last updated on 17/05/2022

Authorisation details

Product details
Leflunomide Zentiva (previously Leflunomide Winthrop)
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Arthritis, Rheumatoid
  • Arthritis, Psoriatic
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Zentiva k.s.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

U kabelovny 130
102 37 Prague 10
Czech Republic

Product information

13/05/2022 Leflunomide Zentiva (previously Leflunomide Winthrop) - EMEA/H/C/001129 - IB/0037

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


Therapeutic indication

Leflunomide is indicated for the treatment of adult patients with:

  • active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD);
  • active psoriatic arthritis.

Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.

Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.

Assessment history

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