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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Leflunomide medac   

   This product is authorised under a different brand name in the EU in the following languages:
   - Лефлуномид медак (Leflunomide medac) (BG)
   - Leflunomid medac (CS)
   - Leflunomid medac (DA)
   - Leflunomid medac (DE)
   - Leflunomida medac (ES)
   - Leflunomid medac (PL)
   - Leflunomida medac (PT)
   - Leflunomidă medac (RO)
Auth. number : EU/1/10/637
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 may also increase the risk of serious adverse reactions even for a long time after the switching.
Marketing Authorisation Holder: medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstraße 6, 22880 Wedel, 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
29/07/2010 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1227 (2010)5336 of 28/07/2010
30/07/2010 Centralised - Authorisation EMEA/H/C/1227 (2010)5335 of 27/07/2010
06/11/2010 Corrigendum (2010)5335 of 27/07/2010
01/03/2011 Centralised - Variation EMEA/H/C/1227/IB/1
28/06/2011 Centralised - Variation EMEA/H/C/1227/IB/4
Updated with Decision(2012)585 of 30/01/2012
08/09/2011 Centralised - Variation EMEA/H/C/1227/IB/3
Updated with Decision(2012)585 of 30/01/2012
20/09/2011 Centralised - Variation EMEA/H/C/1227/IB/7
Updated with Decision(2012)585 of 30/01/2012
19/12/2011 Centralised - Variation EMEA/H/C/1227/IB/8
Updated with Decision(2012)585 of 30/01/2012
01/02/2012 Centralised - Variation (2012)585 of 30/01/2012
20/06/2012 Centralised - Variation EMEA/H/C/1227/IB/9
Updated with Decision(2012)7873 of 29/10/2012
19/09/2012 Centralised - Notification EMEA/H/C/1227/N/10
Updated with Decision(2012)7873 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7873 of 29/10/2012
28/01/2013 Centralised - Variation EMEA/H/C/1227/IB/13
Updated with Decision(2013)4942 of 25/07/2013
29/07/2013 Centralised - Variation EMEA/H/C/1227/X/12 (2013)4942 of 25/07/2013
23/03/2014 Centralised - Variation EMEA/H/C/1227/IB/15
Updated with Decision(2015)2120 of 23/03/2015
10/06/2014 Centralised - Variation EMEA/H/C/1227/IAIN/16
Updated with Decision(2015)2120 of 23/03/2015
29/09/2014 Centralised - Variation EMEA/H/C/1227/IB/18
Updated with Decision(2015)2120 of 23/03/2015
25/03/2015 Centralised - Renewal EMEA/H/C/1227/R/19 (2015)2120 of 23/03/2015
31/07/2015 Centralised - Variation EMEA/H/C/1227/IA/23
Updated with Decision(2016)4752 of 15/07/2016
10/12/2015 Centralised - Variation EMEA/H/C/1227/IAIN/25
Updated with Decision(2016)4752 of 15/07/2016
19/07/2016 Centralised - Yearly update (2016)4752 of 15/07/2016
18/07/2017 Centralised - Variation EMEA/H/C/1227/IAIN/27
30/01/2018 Centralised - Notification EMEA/H/C/1227/N/29