Repso

Withdrawn

This medicine's authorisation has been withdrawn

leflunomide

Overview

The marketing authorisation for Repso has been withdrawn at the request of the marketing authorisation holder.

Repso : EPAR - Summary for the public

Reference Number: EMA/149379/2011

Product information

Repso : EPAR - Product Information

Latest procedure affecting product information: IA/0020

30/03/2016

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

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
• 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