Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Combivir   
Auth. number : EU/1/98/058
INN : 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: J05AR01 - Zidovudine and lamivudine
(See WHO ATC Index)
Indication: Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection
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
19/03/1998 Centralised - Authorisation EMEA/H/C/190 (1998)695 of 18/03/1998
18/08/1998 Centralised - Notification EMEA/H/C/190/N/1 (1998)2523 of 17/08/1998
19/08/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/I/2-4
19/08/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/I/5
20/10/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/I/7-9
16/11/1999 Centralised - Variation EMEA/H/C/190/II/6 (1999)3716 of 16/11/1999
28/12/2000 Centralised - Variation EMEA/H/C/190/II/10 (2000)4281 of 27/12/2000
02/08/2001 Centralised - Variation EMEA/H/C/190/II/11 (2001)2051 of 31/07/2001
13/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/I/13
15/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/I/14
27/08/2002 Centralised - Variation EMEA/H/C/190/II/12 (2002)3184 of 22/08/2002
29/08/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/I/15
13/06/2003 Centralised - Renewal EMEA/H/C/190/R/16 (2003)1896 of 11/06/2003
23/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/I/19
20/08/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/I/20
20/08/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/I/18
16/01/2004 Centralised - Variation EMEA/H/C/190/II/22 (2004)90 of 14/01/2004
09/02/2004 Centralised - Variation EMEA/H/C/190/II/21 (2004)411 of 05/02/2004
10/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IB/25
10/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IA/27
01/06/2004 Centralised - Variation EMEA/H/C/190/II/26 (2004)1982 of 26/05/2004
30/07/2004 Centralised - Variation EMEA/H/C/190/IA/28
Updated with Decision(2005)24 of 05/01/2005
07/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IA/29
07/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IB/30
07/01/2005 Centralised - Variation EMEA/H/C/190/II/31 (2005)24 of 05/01/2005
09/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IB/35
15/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IA/32
14/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IA/33
12/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IA/36
10/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IB/34
19/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IA/37
19/07/2006 Centralised - Variation EMEA/H/C/190/IA/38
Updated with Decision(2007)313 of 26/01/2007
27/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IA/40
13/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IB/39
30/01/2007 Centralised - Variation EMEA/H/C/190/II/41 (2007)313 of 26/01/2007
20/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IA/46
28/02/2007 Centralised - Variation EMEA/H/C/190/IA/47
Updated with Decision(2007)4189 of 03/09/2007
01/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/II/42
05/09/2007 Centralised - Variation EMEA/H/C/190/II/48 (2007)4189 of 03/09/2007
16/11/2007 Centralised - Variation EMEA/H/C/190/II/43 (2007)5599 of 13/11/2007
27/11/2007 Centralised - Variation EMEA/H/C/190/II/44 (2007)5844 of 23/11/2007
29/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/II/50
15/02/2008 Centralised - Renewal EMEA/H/C/190/R/49 (2008)682 of 13/02/2008
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IA/54
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IA/53
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/190/IA/52
18/09/2008 Centralised - Variation EMEA/H/C/190/II/51 (2008)5251 of 16/09/2008
04/04/2009 Centralised - Variation EMEA/H/C/190/II/55 (2009)2697 of 02/04/2009
28/01/2010 Centralised - Variation EMEA/H/C/190/II/56 (2010)529 of 25/01/2010
12/05/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/190/T/57 (2010)3159 of 10/05/2010
09/09/2010 Centralised - Notification EMEA/H/C/190/N/58
Updated with Decision(2010)7738 of 03/11/2010
09/11/2010 Centralised - Variation EMEA/H/C/190/II/60 (2010)7738 of 03/11/2010
04/05/2011 Centralised - Variation EMEA/H/C/190/II/59 (2011)3083 of 02/05/2011
28/03/2013 Centralised - 2-Monthly update EMEA/H/C/190/WS/338 (2013)1903 of 26/03/2013
29/05/2013 Centralised - 2-Monthly update EMEA/H/C/190/WS/361 (2013)3237 of 27/05/2013
27/11/2013 Centralised - Notification EMEA/H/C/190/N/74
25/04/2014 Centralised - Variation EMEA/H/C/190/WS/544