Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Repso   
Auth. number : EU/1/11/674
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: Teva B.V.
Swensweg 5, 2031 GA Haarlem, 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
16/03/2011 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1222 (2011)1785 of 14/03/2011
17/03/2011 Centralised - Authorisation EMEA/H/C/1222 (2011)1784 of 14/03/2011
11/08/2011 Centralised - Variation EMEA/H/C/1222/IB/2
Updated with Decision(2012)1558 of 06/03/2012
06/09/2011 Centralised - Variation EMEA/H/C/1222/IB/3
Updated with Decision(2012)1558 of 06/03/2012
05/12/2011 Centralised - Variation EMEA/H/C/1222/IB/5
Updated with Decision(2012)1558 of 06/03/2012
08/03/2012 Centralised - Variation (2012)1558 of 06/03/2012
11/06/2012 Centralised - Variation EMEA/H/C/1222/IB/7
Updated with Decision(2012)7906 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7906 of 29/10/2012
28/01/2013 Centralised - Variation EMEA/H/C/1222/IB/9
Updated with Decision(2014)785 of 06/02/2014
26/04/2013 Corrigendum (2011)1784 of 14/03/2011
15/01/2014 Centralised - Notification EMEA/H/C/1222/N/12
Updated with Decision(2014)785 of 06/02/2014
11/02/2014 Centralised - Yearly update (2014)785 of 06/02/2014
11/07/2014 Centralised - Variation EMEA/H/C/1222/IB/13
Updated with Decision(2014)8407 of 07/11/2014
12/11/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1222/T/14 (2014)8407 of 07/11/2014
14/04/2015 Centralised - Variation EMEA/H/C/1222/IB/16/G
Updated with Decision(2016)290 of 18/01/2016
18/08/2015 Centralised - Variation EMEA/H/C/1222/IA/19
Updated with Decision(2016)290 of 18/01/2016
20/01/2016 Centralised - Renewal EMEA/H/C/1222/R/18 (2016)290 of 18/01/2016
30/03/2016 Centralised - Variation EMEA/H/C/1222/IA/20