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Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Leflunomide ratiopharm   

   This product is authorised under a different brand name in the EU in the following languages:
   - Лефлуномид ратиофарм (Leflunomide ratiopharm) (BG)
   - Leflunomid ratiopharm (DE)
   - Leflunomida ratiopharm (ES)
   - Leflunomida ratiopharm (PT)
   - Leflunomidă ratiopharm (RO)
Auth. number : EU/1/10/654
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: ratiopharm GmbH
Graf-Arco-Straße 3, 89079 Ulm, 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
01/12/2010 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/2035 (2010)8663 of 29/11/2010
06/12/2010 Centralised - Authorisation EMEA/H/C/2035 (2010)8664 of 29/11/2010
15/03/2011 Centralised - Variation EMEA/H/C/2035/IB/1
Updated with Decision(2011)6935 of 22/09/2011
20/08/2011 Centralised - Variation EMEA/H/C/2035/IB/3
Updated with Decision(2011)6935 of 22/09/2011
07/09/2011 Centralised - Variation EMEA/H/C/2035/IB/4
Updated with Decision(2011)6935 of 22/09/2011
26/09/2011 Centralised - Variation (2011)6935 of 22/09/2011
17/01/2012 Centralised - Variation EMEA/H/C/2035/IB/6
Updated with Decision(2012)6712 of 20/09/2012
11/06/2012 Centralised - Variation EMEA/H/C/2035/IB/8
Updated with Decision(2012)6712 of 20/09/2012
24/09/2012 Centralised - Variation (2012)6712 of 20/09/2012
06/02/2013 Centralised - Variation EMEA/H/C/2035/IB/9
Updated with Decision(2014)418 of 22/01/2014
24/01/2014 Centralised - Yearly update (2014)418 of 22/01/2014
06/02/2014 Centralised - Variation EMEA/H/C/2035/IB/12
Updated with Decision(2015)744 of 06/02/2015
14/08/2014 Centralised - Variation EMEA/H/C/2035/IB/13
Updated with Decision(2015)744 of 06/02/2015
10/02/2015 Centralised - Yearly update (2015)744 of 06/02/2015
19/05/2015 Centralised - 2-Monthly update EMEA/H/C/2035/IB/17 (2015)3430 of 13/05/2015
23/06/2015 Centralised - Renewal EMEA/H/C/2035/R/15 (2015)4302 of 19/06/2015
24/09/2015 Centralised - Variation EMEA/H/C/2035/IAIN/18
Updated with Decision(2016)6239 of 22/09/2016
13/11/2015 Centralised - Variation EMEA/H/C/2035/IB/19
Updated with Decision(2016)6239 of 22/09/2016
15/12/2015 Centralised - Variation EMEA/H/C/2035/IAIN/20
Updated with Decision(2016)6239 of 22/09/2016
26/09/2016 Centralised - Yearly update (2016)6239 of 22/09/2016
21/12/2017 Centralised - Variation EMEA/H/C/2035/IAIN/22