Leflunomide Zentiva (previously Leflunomide Winthrop)

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leflunomide

Authorised
This medicine is authorised for use in the European Union.

Overview

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 13/06/2019

Authorisation details

Product details
Name
Leflunomide Zentiva (previously Leflunomide Winthrop)
Agency product number
EMEA/H/C/001129
Active substance
leflunomide
International non-proprietary name (INN) or common name
leflunomide
Therapeutic area (MeSH)
  • Arthritis, Rheumatoid
  • Arthritis, Psoriatic
Anatomical therapeutic chemical (ATC) code
L04AA13
Publication details
Marketing-authorisation holder
Zentiva k.s.
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
08/01/2010
Contact address

U kabelovny 130
102 37 Prague 10
Czech Republic

Product information

16/10/2018 Leflunomide Zentiva (previously Leflunomide Winthrop) - EMEA/H/C/001129 - T/0032

Contents

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Pharmacotherapeutic group

Immunosuppressants

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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