Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ziagen   
Auth. number : EU/1/99/112
INN : abacavir sulfate
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: J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors
Chemical substance: J05AF06 - Abacavir
(See WHO ATC Index)
Indication: Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children.The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy.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 Ziagen 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
17/02/2000 Centralised - Variation EMEA/H/C/252/N/1 (2000)317 of 15/02/2000
23/02/2001 Centralised - Variation EMEA/H/C/252/I/2 (2001)259 of 22/02/2001
23/02/2001 Centralised - Variation EMEA/H/C/252/II/3 (2001)259 of 22/02/2001
27/03/2001 Centralised - Variation EMEA/H/C/252/I/4 (2001)790 of 26/03/2001
25/10/2001 Centralised - Variation EMEA/H/C/252/II/5, 6 (2001)2895 of 24/10/2001
07/11/2001 Centralised - Variation EMEA/H/C/252/I/7, 8
10/07/2002 Centralised - Variation EMEA/H/C/252/I/11
11/07/2002 Centralised - Variation EMEA/H/C/252/I/13
11/07/2002 Centralised - Variation EMEA/H/C/252/I/12
11/07/2002 Centralised - Variation EMEA/H/C/252/I/10
30/10/2002 Centralised - Variation EMEA/H/C/252/II/9 (2002)4337 of 28/10/2002
26/02/2003 Centralised - Variation EMEA/H/C/252/I/17
26/02/2003 Centralised - Variation EMEA/H/C/252/I/14
26/03/2003 Centralised - Variation EMEA/H/C/252/I/16
10/04/2003 Centralised - Variation EMEA/H/C/252/I/15 (2003)1243 of 08/04/2003
16/07/2003 Centralised - Variation EMEA/H/C/252/II/18 (2003)2632 of 14/07/2003
03/02/2004 Centralised - Variation EMEA/H/C/252/II/19 (2004)298 of 30/01/2004
11/02/2004 Centralised - Variation EMEA/H/C/252/IA/23
13/02/2004 Centralised - Variation EMEA/H/C/252/IB/22
01/06/2004 Centralised - Variation EMEA/H/C/252/II/24 (2004)1983 of 26/05/2004
12/07/2004 Centralised - Authorisation EMEA/H/C/252 (1999)1908 of 08/07/1999
23/08/2004 Centralised - Renewal EMEA/H/C/252/R/25 (2004)3263 of 18/08/2004
01/11/2004 Centralised - Variation EMEA/H/C/252/II/26 (2004)4301 of 28/10/2004
01/11/2004 Centralised - Variation EMEA/H/C/252/II/20 (2004)4302 of 28/10/2004
22/12/2004 Centralised - Variation EMEA/H/C/252/II/27 (2004)5374 of 17/12/2004
13/05/2005 Centralised - Variation EMEA/H/C/252/IA/28
13/09/2005 Centralised - Variation EMEA/H/C/252/II/29 (2005)3489 of 08/09/2005
09/11/2005 Centralised - Variation EMEA/H/C/252/II/30 (2005)4388 of 07/11/2005
23/12/2005 Centralised - Variation EMEA/H/C/252/IB/31
11/01/2006 Centralised - Variation EMEA/H/C/252/IA/32
Updated with Decision(2006)3840 of 21/08/2006
03/04/2006 Centralised - Variation EMEA/H/C/252/IA/35
Updated with Decision(2006)3840 of 21/08/2006
03/04/2006 Centralised - Variation EMEA/H/C/252/IA/34
24/05/2006 Centralised - Variation EMEA/H/C/252/IA/36
07/06/2006 Centralised - Variation EMEA/H/C/252/II/33
23/08/2006 Centralised - Variation (2006)3840 of 21/08/2006
06/11/2006 Centralised - Variation EMEA/H/C/252/IA/39
01/12/2006 Centralised - Variation EMEA/H/C/252/II/37, 38 (2006)5915 of 28/11/2006
19/01/2007 Centralised - Variation EMEA/H/C/252/II/40 (2007)189 of 17/01/2007
01/06/2007 Centralised - Variation EMEA/H/C/252/II/41 (2007)2354 of 30/05/2007
29/08/2007 Centralised - Variation EMEA/H/C/252/II/43 (2007)4071 of 27/08/2007
03/09/2007 Centralised - Variation EMEA/H/C/252/IA/44
Updated with Decision(2007)5703 of 20/11/2007
16/11/2007 Centralised - Variation EMEA/H/C/252/IB/46
22/11/2007 Centralised - Variation EMEA/H/C/252/II/42 (2007)5703 of 20/11/2007
01/02/2008 Centralised - Variation EMEA/H/C/252/IB/47
04/03/2008 Centralised - Variation EMEA/H/C/252/II/45 (2008)878 of 29/02/2008
03/07/2008 Centralised - Variation EMEA/H/C/252/IA/50
04/09/2008 Centralised - Variation EMEA/H/C/252/II/48 (2008)4952 of 02/09/2008
09/04/2009 Centralised - Variation EMEA/H/C/252/II/52 (2009)2875 of 07/04/2009
03/06/2009 Centralised - Renewal EMEA/H/C/252/R/51 (2009)4338 of 29/05/2009
10/06/2009 Centralised - Variation EMEA/H/C/252/II/49 (2009)4578 of 08/06/2009
30/07/2009 Centralised - Variation EMEA/H/C/252/IA/53
24/11/2009 Centralised - Variation EMEA/H/C/252/II/54 (2009)9341 of 20/11/2009
22/01/2010 Centralised - Variation EMEA/H/C/252/II/55 (2010)366 of 20/01/2010
04/02/2010 Centralised - Variation EMEA/H/C/252/IB/56
18/03/2010 Centralised - Variation EMEA/H/C/252/IB/57
12/05/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/252/T/58 (2010)3167 of 10/05/2010
05/08/2010 Centralised - Variation EMEA/H/C/252/N/59
Updated with Decision(2011)4344 of 15/06/2011
17/04/2011 Centralised - Variation EMEA/H/C/252/IA/61
Updated with Decision(2011)4344 of 15/06/2011
17/06/2011 Centralised - Variation (2011)4344 of 15/06/2011
26/10/2011 Centralised - Variation EMEA/H/C/252/II/62 (2011)7777 of 24/10/2011
01/12/2011 Centralised - Variation EMEA/H/C/252/IA/65
Updated with Decision(2012)4571 of 28/06/2012
03/07/2012 Centralised - Variation (2012)4571 of 28/06/2012
28/03/2013 Centralised - Variation EMEA/H/C/252/WS/338 (2013)1896 of 26/03/2013
24/08/2013 Centralised - Variation EMEA/H/C/252/IB/69
Updated with Decision(2014)2051 of 21/03/2014
26/03/2014 Centralised - Renewal EMEA/H/C/252/R/71 (2014)2051 of 21/03/2014