Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kivexa   
Auth. number : EU/1/04/298
INN : abacavir / Lamivudine
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AR - Antivirals for treatment of hiv infections, combinations
Chemical substance: J05AR02 - Lamivudine and abacavir
(See WHO ATC Index)
Indication: Kivexa is a fixed-dose combination of two nucleoside analogues (abacavir and lamivudine). It is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age (see sections 4.4 and 5.1).

Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir (see “Management after an interruption of Kivexa therapy”). Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing (see section 4.4 and 4.8).
Marketing Authorisation Holder: ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

  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
22/12/2004 Centralised - Authorisation EMEA/H/C/581 (2004)5373 of 17/12/2004
13/09/2005 Centralised - Variation EMEA/H/C/581/II/1 (2005)3488 of 08/09/2005
09/11/2005 Centralised - Variation EMEA/H/C/581/II/2 (2005)4387 of 07/11/2005
12/12/2005 Centralised - Variation EMEA/H/C/581/IA/7
23/12/2005 Centralised - Variation EMEA/H/C/581/IB/4
09/01/2006 Centralised - Variation EMEA/H/C/581/IB/6
10/01/2006 Centralised - Variation EMEA/H/C/581/IB/5
07/06/2006 Centralised - Variation EMEA/H/C/581/II/8
27/07/2006 Centralised - Variation EMEA/H/C/581/IA/11
11/08/2006 Centralised - Variation EMEA/H/C/581/IB/10
01/12/2006 Centralised - Variation EMEA/H/C/581/II/9 (2006)5922 of 28/11/2006
19/01/2007 Centralised - Variation EMEA/H/C/581/II/12 (2007)183 of 17/01/2007
20/02/2007 Centralised - Variation EMEA/H/C/581/IA/14
01/06/2007 Centralised - Variation EMEA/H/C/581/II/13 (2007)2355 of 30/05/2007
29/08/2007 Centralised - Variation EMEA/H/C/581/II/15 (2007)4069 of 27/08/2007
19/11/2007 Centralised - Variation EMEA/H/C/581/IB/17
Updated with Decision(2008)865 of 29/02/2008
29/01/2008 Centralised - Variation EMEA/H/C/581/II/20
04/03/2008 Centralised - Variation EMEA/H/C/581/II/18 (2008)865 of 29/02/2008
22/09/2008 Centralised - Variation EMEA/H/C/581/IA/22
Updated with Decision(2009)3136 of 21/04/2009
23/04/2009 Centralised - Variation (2009)3136 of 21/04/2009
10/06/2009 Centralised - Variation EMEA/H/C/581/II/21 (2009)4579 of 08/06/2009
27/11/2009 Centralised - Variation EMEA/H/C/581/II/24 (2009)9498 of 25/11/2009
16/12/2009 Centralised - Renewal EMEA/H/C/581/R/23 (2009)10334 of 11/12/2009
12/01/2010 Centralised - Variation EMEA/H/C/581/IA/28
09/02/2010 Centralised - Variation EMEA/H/C/581/IB/26
09/02/2010 Centralised - Variation EMEA/H/C/581/IB/27
28/05/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/581/T/30 (2010)3492 of 26/05/2010
02/08/2010 Centralised - Variation EMEA/H/C/581/II/25 (2010)5384 of 28/07/2010
03/08/2010 Centralised - Variation EMEA/H/C/581/N/31
Updated with Decision(2011)1917 of 18/03/2011
08/10/2010 Centralised - Variation EMEA/H/C/581/IA/33
Updated with Decision(2011)1917 of 18/03/2011
23/03/2011 Centralised - Variation EMEA/H/C/581/II/34 (2011)1917 of 18/03/2011
12/05/2011 Centralised - Variation EMEA/H/C/581/II/32/G (2011)3229 of 06/05/2011
26/10/2011 Centralised - Variation EMEA/H/C/581/II/35 (2011)7801 of 24/10/2011
10/08/2012 Centralised - Variation EMEA/H/C/581/WS/163 (2012)5759 of 08/08/2012
21/02/2013 Centralised - Variation EMEA/H/C/581/II/39
Updated with Decision(2013)1897 of 26/03/2013
28/03/2013 Centralised - Variation EMEA/H/C/581/WS/338/40 (2013)1897 of 26/03/2013
29/05/2013 Centralised - Variation EMEA/H/C/581/WS/361 (2013)3235 of 27/05/2013
12/12/2013 Centralised - Variation EMEA/H/C/581/N/46