Repso

Withdrawn

This medicine's authorisation has been withdrawn

leflunomide

Overview

On 19 July 2017, the European Commission withdrew the marketing authorisation for Repso (leflunomide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Teva B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Repso was granted marketing authorisation in the EU on 14 March 2011 for the treatment of active rheumatoid and active psoriatic arthritis. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2016. Repso is a generic medicine of Arava. There are other generic medicinal products of Arava authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Repso is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Repso : EPAR - Summary for the public

Reference Number: EMA/149379/2011

Product information

Repso : EPAR - Product Information

Repso : EPAR - All Authorised presentations

Repso : EPAR - Conditions imposed on member states for safe and effective use - Annex IV

Product details

• Name of medicine:
  Repso
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/001222
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Teva B.V.

  Swensweg 5; 2031GA Haarlem; The Netherlands

• Marketing authorisation issued:
  14/03/2011
• Withdrawal of marketing authorisation:
  19/07/2017
• Revision:
  11

Assessment history

Changes since initial authorisation of medicine

Repso : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Repso : EPAR - Public assessment report

AdoptedReference Number: EMA/79461/2011

CHMP summary of positive opinion for Repso

AdoptedReference Number: EMA/CHMP/605155/2010