Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Trizivir   
Auth. number : EU/1/00/156
INN : abacavir, lamivudine, zidovudine
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: Treatment of Human Immunodeficiency Virus (HIV) infection in adults. This fixed combination replaces the three components (abacavir, lamivudine and zidovudine) used separately in similar doses. It is recommended that treatment is started with abacavir, lamivudine, and zidovudine separately for the first 6-8 weeks The choice of this fixed combination should be based not only on potential adherence criteria, but mainly on expected efficacy and risk related to the three nucleoside analogues.
The demonstration of the benefit of Trizivir is mainly based on results of studies performed in treatment naive patients or moderately antiretroviral experienced patients with non-advanced disease. In patients with high viral load (> 100,000 copies/ml) choice of therapy needs special consideration.
Overall, the virologic suppression with this triple nucleoside regimen could be inferior to that obtained with other multitherapies notably including boosted Protease inhibitors or non nucleoside reverse transcriptase inhibitors, therefore the use of Trizivir should only be considered under special circumstances (e.g. co-infection with tuberculosis).
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 Trizivir 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
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
02/01/2001 Centralised - Authorisation EMEA/H/C/338 (2000)4297 of 28/12/2000
18/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/I/3
12/11/2001 Centralised - Variation EMEA/H/C/338/II/1 (2001)3517 of 09/11/2001
28/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/I/2
13/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/I/4
22/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/I/6, 9
21/10/2002 Centralised - Variation EMEA/H/C/338/II/5 (2002)4058 of 17/10/2002
03/07/2003 Centralised - Variation EMEA/H/C/338/II/10 (2003)2231 of 30/06/2003
22/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/I/13
12/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/I/14
18/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/I/12
16/01/2004 Centralised - Variation EMEA/H/C/338/II/15 (2004)93 of 14/01/2004
03/02/2004 Centralised - Variation EMEA/H/C/338/II/16 (2004)302 of 30/01/2004
09/02/2004 Centralised - Notification EMEA/H/C/338/N/19 (2004)402 of 05/02/2004
16/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IB/18
10/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IA/22
01/06/2004 Centralised - Variation EMEA/H/C/338/II/21 (2004)1987 of 26/05/2004
10/09/2004 Centralised - Variation EMEA/H/C/338/IA/23
Updated with Decision(2004)4486 of 17/11/2004
10/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IA/24
19/11/2004 Centralised - Variation EMEA/H/C/338/II/25 (2004)4486 of 17/11/2004
24/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IA/27
07/01/2005 Centralised - Variation EMEA/H/C/338/II/26 (2005)21 of 05/01/2005
30/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IA/28
14/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IA/30
09/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IA/34
09/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IB/31
09/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IB/33
10/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IB/32
13/04/2006 Centralised - Renewal EMEA/H/C/338/R/29 (2006)1612 of 10/04/2006
07/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/II/35
03/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IA/38
09/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IB/37
24/11/2006 Centralised - Variation EMEA/H/C/338/II/36, 39 (2006)5725 of 22/11/2006
26/01/2007 Centralised - Variation EMEA/H/C/338/II/40 (2007)258 of 24/01/2007
20/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IA/44
28/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/II/41
06/06/2007 Centralised - Variation EMEA/H/C/338/II/42 (2007)2453 of 04/06/2007
05/09/2007 Centralised - Variation EMEA/H/C/338/II/45 (2007)4188 of 03/09/2007
16/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IB/47
23/11/2007 Centralised - Variation EMEA/H/C/338/II/43 (2007)5745 of 21/11/2007
28/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/II/48
03/03/2008 Centralised - Variation EMEA/H/C/338/II/46 (2008)838 of 28/02/2008
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IA/50, 51, 52
13/08/2008 Centralised - Variation EMEA/H/C/338/IA/53
Updated with Decision(2009)2468 of 27/03/2009
01/04/2009 Centralised - Variation (2009)2468 of 27/03/2009
29/05/2009 Centralised - Variation EMEA/H/C/338/II/49 (2009)4241 of 27/05/2009
23/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IA/56
25/09/2009 Centralised - Notification EMEA/H/C/338/N/55
Updated with Decision(2009)9449 of 23/11/2009
25/11/2009 Centralised - Variation EMEA/H/C/338/II/57 (2009)9449 of 23/11/2009
10/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IB/58
10/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/338/IB/59
19/05/2010 Centralised - Variation EMEA/H/C/338/IA/60/G (2010)3215 of 12/05/2010
Updated with Decision(2010)3215 of 12/05/2010
28/05/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/338/T/61 (2010)3486 of 26/05/2010
02/12/2010 Centralised - Renewal EMEA/H/C/338/R/63 (2010)8654 of 29/11/2010
09/06/2011 Centralised - Variation EMEA/H/C/338/II/62 (2011)4167 of 07/06/2011
25/05/2012 Centralised - Variation EMEA/H/C/338/IB/68
Updated with Decision(2012)4847 of 06/07/2012
10/07/2012 Centralised - Variation EMEA/H/C/338/WS/163 (2012)4847 of 06/07/2012
28/03/2013 Centralised - 2-Monthly update EMEA/H/C/338/II/70, EMEA/H/C/338/II/WS/338 (2013)1901 of 26/03/2013
28/05/2013 Centralised - 2-Monthly update EMEA/H/C/338/WS/361 (2013)3154 of 23/05/2013
27/01/2014 Centralised - Notification EMEA/H/C/338/N/77
25/04/2014 Centralised - Variation EMEA/H/C/338/IB/WS/544