- Application under evaluation
- CHMP opinion
- European Commission decision
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Report (EPAR) for Leflunomide Teva is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
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).
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
ImmunosuppressantsTherapeutic 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.