Leflunomide Zentiva (previously Leflunomide Winthrop)
What Leflunomide Zentiva (previously Leflunomide Winthrop) is used for
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.
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Leflunomide Zentiva (previously Leflunomide Winthrop)
- Active substance
- leflunomide
- Disease area
- Arthritis, Rheumatoid; Arthritis, Psoriatic
- Medicine group
- immunosuppressants
- ATC code
- L04AK01
- Marketing authorisation holder
- Zentiva k.s.
- Authorised in the EU since
- 2010
Official information
In India
- Leflunomide: 68 brands in India
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Leflunomide Zentiva (previously Leflunomide Winthrop) used for?
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…
What is the active substance in Leflunomide Zentiva (previously Leflunomide Winthrop)?
Leflunomide Zentiva (previously Leflunomide Winthrop) contains leflunomide.
Who makes Leflunomide Zentiva (previously Leflunomide Winthrop)?
The EU marketing authorisation holder is Zentiva k.s..
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, EU