Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kineret   
Auth. number : EU/1/02/203
INN : Anakinra
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AC - Interleukin inhibitors
Chemical substance: L04AC03 - Anakinra
(See WHO ATC Index)
Indication: Kineret is indicated for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.

Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including:
- Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)
- Muckle-Wells Syndrome (MWS)
- Familial Cold Autoinflammatory Syndrome (FCAS)
Marketing Authorisation Holder: Swedish Orphan Biovitrum AB (publ)
SE-112 76, Stockholm, Sverige

  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
12/03/2002 Centralised - Authorisation EMEA/H/C/363 (2002)1045 of 08/03/2002
10/07/2002 Centralised - Variation EMEA/H/C/363/I/2
15/07/2002 Centralised - Variation EMEA/H/C/363/I/1 (2002)2732 of 11/07/2002
29/10/2002 Centralised - Variation EMEA/H/C/363/N/4 (2002)4289 of 23/10/2002
28/04/2003 Centralised - Variation EMEA/H/C/363/II/6 (2003)1427 of 23/04/2003
26/05/2003 Centralised - Variation EMEA/H/C/363/II/7
24/11/2003 Centralised - Variation EMEA/H/C/363/II/8
10/12/2004 Centralised - Variation EMEA/H/C/363/N/9
Updated with Decision(2005)2955 of 28/07/2005
01/08/2005 Centralised - Variation EMEA/H/C/363/II/10 (2005)2955 of 28/07/2005
19/10/2005 Centralised - Variation EMEA/H/C/363/II/11
17/11/2005 Centralised - Variation EMEA/H/C/363/IA/12
Updated with Decision(2006)2221 of 31/05/2006
02/06/2006 Centralised - Variation (2006)2221 of 31/05/2006
02/08/2006 Centralised - Variation EMEA/H/C/363/II/13 (2006)3558 of 28/07/2006
22/03/2007 Centralised - Renewal EMEA/H/C/363/R/14 (2007)1234 of 20/03/2007
26/04/2007 Centralised - Variation EMEA/H/C/363/II/16 (2007)1897 of 24/04/2007
26/02/2008 Centralised - Variation EMEA/H/C/3638/II/17
03/04/2008 Centralised - Variation EMEA/H/C/363/II/17 (2008)1306 of 01/04/2008
29/04/2008 Centralised - Variation EMEA/H/C/363/II/18
24/11/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/363/T/19 (2008)7425 of 20/11/2008
20/04/2009 Centralised - Variation EMEA/H/C/363/IA/21
11/06/2009 Centralised - Variation EMEA/H/C/363/IA/22
Updated with Decision(2010)95 of 09/02/2010
02/07/2009 Centralised - Variation EMEA/H/C/363/II/20 (2009)5391 of 30/06/2009
08/10/2009 Centralised - Variation EMEA/H/C/363/IA/23
08/10/2009 Centralised - Variation EMEA/H/C/363/IA/26
08/10/2009 Centralised - Variation EMEA/H/C/363/IA/25
08/10/2009 Centralised - Variation EMEA/H/C/363/IA/24
09/11/2009 Centralised - Variation EMEA/H/C/363/IA/27
27/01/2010 Centralised - Variation EMEA/H/C/363/IB/28
Updated with Decision(2010)1949 of 19/03/2010
11/02/2010 Centralised - Variation (2010)95 of 09/02/2010
23/03/2010 Centralised - Variation (2010)1949 of 19/03/2010
12/11/2010 Centralised - Variation EMEA/H/C/363/IA/30/G
Updated with Decision(2011)1210 of 21/02/2011
04/02/2011 Centralised - Variation EMEA/H/C/363/IA/31/G
Updated with Decision(2011)2694 of 12/04/2011
25/02/2011 Centralised - Variation EMEA/H/C/363/II/29 (2011)1210 of 21/02/2011
14/04/2011 Centralised - Variation (2011)2694 of 12/04/2011
30/11/2011 Centralised - Variation EMEA/H/C/363/N/32
Updated with Decision(2012)7767 of 25/10/2012
22/06/2012 Centralised - Variation EMEA/H/C/363/IB/38
Updated with Decision(2012)7767 of 25/10/2012
30/10/2012 Centralised - Variation (2012)7767 of 25/10/2012
11/01/2013 Centralised - Variation EMEA/H/C/363/IB/41/G
Updated with Decision(2013)8153 of 15/11/2013
19/11/2013 Centralised - Variation EMEA/H/C/363/X/42 (2013)8153 of 15/11/2013
01/07/2014 Centralised - Variation EMEA/H/C/363/IB/49 (2014)4494 of 27/06/2014