Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Arava   
Auth. number : EU/1/99/118
INN : 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
07/09/1999 Centralised - Authorisation EMEA/H/C/235 (1999)2850 of 02/09/1999
15/12/1999 Centralised - Variation EMEA/H/C/235/I/1 (1999)4277 of 08/12/1999
27/03/2000 Centralised - Variation EMEA/H/C/235/II/2 (2000)723 of 16/03/2000
07/07/2000 Centralised - Variation EMEA/H/C/235/N/4 (2000)1743 of 04/07/2000
20/11/2000 Centralised - Variation EMEA/H/C/235/I/6 (2000)3244 of 16/11/2000
02/05/2001 Centralised - Variation EMEA/H/C/235/I/9
08/08/2001 Centralised - Variation EMEA/H/C/235/II/10 (2001)2050 of 31/07/2001
11/12/2001 Centralised - Variation EMEA/H/C/235/N/11 (2001)3864 of 27/11/2001
07/01/2002 Centralised - Variation EMEA/H/C/235/I/14
25/02/2002 Centralised - Variation EMEA/H/C/235/I/12 (2002)652 of 19/02/2002
25/02/2002 Centralised - Variation EMEA/H/C/235/I/13 (2002)654 of 19/02/2002
08/03/2002 Centralised - Variation EMEA/H/C/235/I/15, 16
03/04/2002 Centralised - Variation EMEA/H/C/235/I/17 (2002)1291 of 22/03/2002
22/07/2002 Centralised - Variation EMEA/H/C/235/II/18 (2002)2838 of 18/07/2002
18/02/2003 Centralised - Variation EMEA/H/C/235/I/19 (2003)602 of 14/02/2003
23/10/2003 Centralised - Variation EMEA/H/C/235/II/20 (2003)3963 of 20/10/2003
30/01/2004 Centralised - Variation EMEA/H/C/235/II/21 (2004)223 of 27/01/2004
29/04/2004 Centralised - Variation EMEA/H/C/235/IA/25
Updated with Decision(2004)2111 of 10/06/2004
16/06/2004 Centralised - Variation EMEA/H/C/235/II/23 (2004)2111 of 10/06/2004
18/06/2004 Centralised - Variation EMEA/H/C/235/II/22 (2004)2085 of 08/06/2004
18/10/2004 Centralised - Renewal EMEA/H/C/235/R/24 (2004)4052 of 13/10/2004
08/12/2004 Centralised - Variation EMEA/H/C/235/II/26 (2004)4851 of 06/12/2004
21/09/2005 Centralised - Variation EMEA/H/C/235/II/27 (2005)3610 of 19/09/2005
18/11/2005 Centralised - Variation EMEA/H/C/235/II/28 (2005)4488 of 15/11/2005
16/12/2005 Centralised - Variation EMEA/H/C/235/IA/30
Updated with Decision(2006)3179 of 06/07/2006
16/12/2005 Centralised - Variation EMEA/H/C/235/IA/31
Updated with Decision(2006)3179 of 06/07/2006
11/01/2006 Centralised - Variation EMEA/H/C/235/II/29 (2006)34 of 09/01/2006
10/07/2006 Centralised - Variation (2006)3179 of 06/07/2006
13/09/2006 Centralised - Variation EMEA/H/C/235/IA/32
02/02/2007 Centralised - Variation EMEA/H/C/235/N/33
Updated with Decision(2007)5509 of 08/11/2007
17/10/2007 Centralised - Variation EMEA/H/C/235/IB/35
12/11/2007 Centralised - Variation EMEA/H/C/235/II/34 (2007)5509 of 08/11/2007
13/11/2007 Centralised - Variation EMEA/H/C/235/IB/37
13/11/2007 Centralised - Variation EMEA/H/C/235/IB/36
28/02/2008 Centralised - Variation EMEA/H/C/235/II/38 (2008)818 of 26/02/2008
29/04/2008 Centralised - Variation EMEA/H/C/235/IA/40
Updated with Decision(2009)1020 of 11/02/2009
15/05/2008 Centralised - Variation EMEA/H/C/235/IB/39
12/06/2008 Corrigendum (2008)2747 of 10/06/2008
12/02/2009 Centralised - Variation (2009)1020 of 11/02/2009
11/03/2009 Centralised - Variation EMEA/H/C/235/IA/42
03/07/2009 Centralised - Renewal EMEA/H/C/235/R/41 (2009)5429 of 01/07/2009
11/08/2009 Centralised - Variation EMEA/H/C/235/IA/44
30/10/2009 Centralised - Variation EMEA/H/C/235/II/43 (2009)8514 of 28/10/2009
29/01/2010 Centralised - Variation EMEA/H/C/235/II/45 (2010)600 of 27/01/2010
03/05/2010 Centralised - Variation EMEA/H/C/235/II/46 (2010)2926 of 29/04/2010
27/05/2010 Centralised - Variation EMEA/H/C/235/IG/4/G
Updated with Decision(2010)5606 of 06/08/2010
10/08/2010 Centralised - Variation (2010)5606 of 06/08/2010
21/04/2011 Centralised - Variation EMEA/H/C/235/II/48 (2011)2859 of 18/04/2011
12/08/2011 Centralised - Variation EMEA/H/C/235/II/47 (2011)5951 of 10/08/2011
15/11/2011 Centralised - Variation EMEA/H/C/235/II/49 (2011)8245 of 10/11/2011
21/03/2012 Centralised - Variation EMEA/H/C/235/II/50 (2012)1913 of 19/03/2012
20/12/2012 Centralised - Variation EMEA/H/C/235/WS/271 (2012)9871 of 18/12/2012
05/11/2013 Centralised - Variation EMEA/H/C/235/IG/354
05/11/2013 Centralised - Variation EMEA/H/C/235/IG/354
22/05/2014 Centralised - Variation EMEA/H/C/235/WS/526