Leflunomide Teva

Lapsed

This medicine's authorisation has lapsed

leflunomide

Overview

On 10 March 2014, the marketing authorisation of Leflunomide Teva ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Teva Pharma B.V., had not marketed Leflunomide Teva in the EU since its initial marketing authorisation in March 2011. 

In accordance with provisions of the sunset clause1 , the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. Leflunomide Teva was granted marketing authorisation in the EU on 10 March 2011 for the treatment of adult patients with active rheumatoid arthritis. The marketing authorisation was initially valid for a 5-year period. 

Leflunomide Teva is a generic medicine of Arava which is authorised in the EU to treat adult patients with active rheumatoid arthritis and active psoriatic arthritis. Leflunomide Teva was a duplicate application to Repso, which is marketed in the EU. The marketing authorisation holder will maintain the marketing authorisation for Repso. 

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Report (EPAR) for Leflunomide Teva is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Leflunomide Teva : EPAR - Summary for the public

Product information

Leflunomide Teva : EPAR - Product Information

Leflunomide Teva : EPAR - All Authorised presentations

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

Product details

• Name of medicine:
  Leflunomide Teva
• Active substance:
  leflunomide
• International non-proprietary name (INN) or common name:
  leflunomide
• Therapeutic area (MeSH):
  Arthritis, Rheumatoid
• 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).

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/002356
• 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 Pharma B.V.

  Computerweg 10; NL-3542 DR Utrecht; The Netherlands

• Marketing authorisation issued:
  10/03/2011
• Lapse of marketing authorisation:
  10/03/2014
• Revision:
  6

Assessment history

Changes since initial authorisation of medicine

Leflunomide Teva : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Leflunomide Teva : EPAR - Public assessment report

Adopted Reference Number: EMA/79144/2011

CHMP summary of positive opinion for Leflunomide Teva

Adopted Reference Number: EMA/CHMP/605159/2010