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Community register of medicinal products for human use


Product information

Invented name: Leflunomide Winthrop   

   This product is authorised under a different brand name in the EU in the following languages:
   - Leflunomid Winthrop (CS)
   - Leflunomid Winthrop (DA)
   - Leflunomid Winthrop (DE)
   - Leflunomida Winthrop (ES)
   - Leflunomid Winthrop (SK)
Auth. number : EU/1/09/604
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),
• 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 (see section 4.4) may also increase the risk of serious adverse reactions even for a long time after the switching.
Marketing Authorisation Holder: Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland
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
12/01/2010 Centralised - Authorisation EMEA/H/C/1129 (2010)62 of 8/01/2010
26/05/2010 Centralised - Variation EMEA/H/C/1129/IB/2
Updated with Decision(2010)5848 of 18/08/2010
14/06/2010 Centralised - Variation EMEA/H/C/1129/IG/4/G
Updated with Decision(2010)5848 of 18/08/2010
20/08/2010 Centralised - Variation (2010)5848 of 18/08/2010
21/04/2011 Centralised - Variation EMEA/H/C/1129/II/4 (2011)2860 of 18/04/2011
2/08/2011 Centralised - Variation EMEA/H/C/1129/II/3 (2011)5601 of 27/07/2011
1/11/2011 Centralised - Variation EMEA/H/C/1129/II/5 (2011)7928 of 27/10/2011
21/03/2012 Centralised - Variation EMEA/H/C/1129/II/6 (2012)1908 of 19/03/2012
27/12/2012 Centralised - Variation EMEA/H/C/1129/WS/271 (2012)9931 of 20/12/2012
5/11/2013 Centralised - Variation EMEA/H/C/1129/IG/354
Updated with Decision(2014)8902 of 19/11/2014
22/05/2014 Centralised - Variation EMEA/H/C/1129/WS/526
Updated with Decision(2014)8902 of 19/11/2014
25/09/2014 Centralised - Variation EMEA/H/C/1129/WS/560
Updated with Decision(2014)8902 of 19/11/2014
21/11/2014 Centralised - Renewal EMEA/H/C/1129/R/18 (2014)8902 of 19/11/2014
22/10/2015 Centralised - Variation EMEA/H/C/1129/WS/816/G
Updated with Decision(2016)6716 of 14/10/2016
14/12/2015 Centralised - Variation EMEA/H/C/1129/IG/635
Updated with Decision(2016)6716 of 14/10/2016
19/05/2016 Centralised - Notification EMEA/H/C/1129/N/25
Updated with Decision(2016)6716 of 14/10/2016
18/10/2016 Centralised - Yearly update (2016)6716 of 14/10/2016
14/07/2017 Centralised - Variation EMEA/H/C/1129/IG/823
9/04/2018 Centralised - Notification EMEA/H/C/1129/N/30