Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Leflunomide Teva

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Leflunomid Teva (DE)
   - Leflunomida Teva (PT)
   - Leflunomid Teva (SL)
Auth. number : EU/1/11/675
Active substance : leflunomide
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AA - Selective immunosuppressive agents
Chemical substance: L04AA13 - Leflunomide
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
11/03/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2356 (2011)1719 of 10/03/2011
14/03/2011 Centralised - Authorisation EMEA/H/C/2356 (2011)1720 of 10/03/2011
11/08/2011 Centralised - Variation EMEA/H/C/2356/IB/2
Updated with Decision(2012)1504 of 02/03/2012
09/09/2011 Centralised - Variation EMEA/H/C/2356/IB/3
Updated with Decision(2012)1504 of 02/03/2012
19/12/2011 Centralised - Variation EMEA/H/C/2356/IB/5
Updated with Decision(2012)1504 of 02/03/2012
06/03/2012 Centralised - Variation (2012)1504 of 02/03/2012
11/06/2012 Centralised - Variation EMEA/H/C/2356/IB/6
Updated with Decision(2012)7934 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7934 of 29/10/2012
28/01/2013 Centralised - Variation EMEA/H/C/2356/IB/8
Updated with Decision(2014)638 of 31/01/2014
19/04/2013 Corrigendum (2011)1720 of 19/04/2013
15/01/2014 Centralised - Notification EMEA/H/C/2356/N/11
Updated with Decision(2014)638 of 31/01/2014
05/02/2014 Centralised - Yearly update (2014)638 of 31/01/2014
10/03/2014 Centralised - Withdrawal