Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Kaletra   
Auth. number : EU/1/01/172
Active substance : lopinavir / Ritonavir
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: J05AR10 - Lopinavir and ritonavir
(See WHO ATC Index)
Indication: Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years.
The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.
Marketing Authorisation Holder: AbbVie Ltd
Maidenhead, SL6 4UB, 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
22/03/2001 Centralised - Authorisation EMEA/H/C/368 (2001)544 of 20/03/2001
13/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/I/3
06/03/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/I/4
02/04/2002 Centralised - Variation EMEA/H/C/368/II/2 (2002)1325 of 26/03/2002
02/04/2002 Centralised - Variation EMEA/H/C/368/II/1 (2002)1324 of 26/03/2002
18/09/2002 Centralised - Variation EMEA/H/C/368/II/6 (2002)3427 of 13/09/2002
18/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/I/7
25/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/I/12
25/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/I/9
25/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/I/10
25/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/I/11
09/10/2002 Centralised - Variation EMEA/H/C/368/I/8 (2002)3794 of 07/10/2002
14/11/2002 Centralised - Annual reassessment EMEA/H/C/368/S/5 (2002)4499 of 12/11/2002
15/11/2002 Centralised - Notification EMEA/H/C/368/N/13 (2002)4517 of 13/11/2002
26/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/I/15
15/07/2003 Centralised - Variation EMEA/H/C/368/II/14 (2003)2565 of 09/07/2003
18/08/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/I/17
13/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/I/18
23/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/II/20
03/02/2004 Centralised - Variation EMEA/H/C/368/II/16 (2004)306 of 30/01/2004
03/02/2004 Centralised - Variation EMEA/H/C/368/II/19 (2004)307 of 30/01/2004
13/09/2004 Centralised - Variation EMEA/H/C/368/II/22 (2004)3480 of 09/09/2004
13/09/2004 Centralised - Variation EMEA/H/C/368/II/21 (2004)3480 of 09/09/2004
28/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IB/24
22/12/2004 Centralised - Variation EMEA/H/C/368/II/26 (2004)5384 of 17/12/2004
17/01/2005 Centralised - Variation EMEA/H/C/368/II/25 (2005)102 of 12/01/2005
26/08/2005 Centralised - Variation EMEA/H/C/368/II/28 (2005)3284 of 24/08/2005
16/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/29
18/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/30
10/04/2006 Centralised - Renewal EMEA/H/C/368/R/31 (2006)1577 of 06/04/2006
28/06/2006 Centralised - Variation EMEA/H/C/368/X/27 (2006)3048 of 27/06/2006
29/06/2006 Centralised - Variation - Decision addressed to Member States EMEA/H/C/368/X/27 (2006)3047 of 27/06/2006
31/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/34
18/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IB/35
08/12/2006 Centralised - Variation EMEA/H/C/368/II/32, 33 (2006)6450 of 04/12/2006
18/01/2007 Centralised - Variation EMEA/H/C/368/II/38 (2007)174 of 16/01/2007
30/03/2007 Centralised - Variation EMEA/H/C/368/II/36, 37 (2007)1512 of 28/03/2007
24/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/39
24/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IB/40
20/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/44
30/07/2007 Centralised - Variation EMEA/H/C/368/II/41 (2007)3704 of 25/07/2007
17/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IB/46
23/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/49
26/10/2007 Centralised - Variation EMEA/H/C/368/II/45, 47, 48 (2007)5303 of 24/10/2007
22/11/2007 Centralised - Variation EMEA/H/C/368/II/43 (2007)5700 of 20/11/2007
20/03/2008 Centralised - Variation EMEA/H/C/368/X/42 (2008)1181 of 18/03/2008
14/05/2008 Centralised - Variation EMEA/H/C/368/IA/64
Updated with Decision(2008)4652 of 22/08/2008
24/06/2008 Centralised - Variation EMEA/H/C/368/II/52 (2008)3194 of 20/06/2008
07/08/2008 Centralised - Variation EMEA/H/C/368/IA/66
Updated with Decision(2008)6603 of 30/10/2008
26/08/2008 Centralised - Variation EMEA/H/C/368/II/53, 61, 63 (2008)4652 of 22/08/2008
08/10/2008 Centralised - Variation EMEA/H/C/368/IB/69
Updated with Decision(2008)7502 of 24/11/2008
04/11/2008 Centralised - Variation EMEA/H/C/368/II/62 (2008)6603 of 30/10/2008
10/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/76
10/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/73
27/11/2008 Centralised - Variation EMEA/H/C/368/II/68 (2008)7502 of 24/11/2008
27/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/78
25/08/2009 Centralised - Variation EMEA/H/C/368/II/67 (2009)6628 of 21/08/2009
17/09/2009 Centralised - Variation EMEA/H/C/368/IB/82
Updated with Decision(2009)9458 of 23/11/2009
25/11/2009 Centralised - Variation EMEA/H/C/368/II/77, 79 (2009)9458 of 23/11/2009
06/01/2010 Centralised - Variation EMEA/H/C/368/IA/86
Updated with Decision(2010)922 of 09/02/2010
06/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/85
11/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/87
12/01/2010 Centralised - Variation EMEA/H/C/368/II/81 (2010)78 of 08/01/2010
09/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IB/84
11/02/2010 Centralised - Variation (2010)922 of 09/02/2010
31/03/2010 Centralised - Variation EMEA/H/C/368/II/83 (2010)2267 of 30/03/2010
13/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/94
13/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/93
13/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/95
14/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/91
14/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/92
15/07/2010 Centralised - Variation EMEA/H/C/368/IA/96
Updated with Decision(2010)6027 of 26/08/2010
02/08/2010 Centralised - Variation EMEA/H/C/368/II/88 (2010)5382 of 28/07/2010
03/08/2010 Centralised - Variation EMEA/H/C/368/IG/14/G
Updated with Decision(2010)9293 of 13/12/2010
03/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/98
03/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/97
19/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/101
19/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IA/100
31/08/2010 Centralised - Variation EMEA/H/C/368/II/89/G, EMEA/H/C/368/II/90 (2010)6027 of 26/08/2010
21/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IB/99
22/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IB/103
22/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IB/104
22/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/368/IB/102
23/09/2010 Centralised - Variation EMEA/H/C/368/IG/22/G
Updated with Decision(2010)9293 of 13/12/2010
15/12/2010 Centralised - Variation (2010)9293 of 13/12/2010
04/03/2011 Centralised - Renewal EMEA/H/C/368/R/107 (2011)1501 of 28/02/2011
23/03/2011 Centralised - Variation EMEA/H/C/368/II/105 (2011)1916 of 18/03/2011
21/04/2011 Centralised - Variation EMEA/H/C/368/II/106 (2011)2852 of 18/04/2011
04/07/2011 Centralised - Variation EMEA/H/C/368/IB/108
Updated with Decision(2012)1264 of 21/02/2012
16/01/2012 Centralised - Variation EMEA/H/C/368/IB/116
Updated with Decision(2012)1264 of 21/02/2012
23/02/2012 Centralised - Variation EMEA/H/C/368/II/110, 114 (2012)1264 of 21/02/2012
03/09/2012 Centralised - Variation EMEA/H/C/368/II/122/G (2012)6121 of 30/08/2012
11/10/2012 Centralised - Variation EMEA/H/C/368/IB/124/G
Updated with Decision(2012)7991 of 31/10/2012
30/10/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/368/T/127 (2012)7761 of 25/10/2012
06/11/2012 Centralised - Variation (2012)7991 of 31/10/2012
17/01/2013 Centralised - Variation EMEA/H/C/368/IG/124/G
Updated with Decision(2013)9759 of 18/12/2013
17/01/2013 Centralised - Variation EMEA/H/C/368/II/123
Updated with Decision(2013)9759 of 18/12/2013
29/01/2013 Centralised - Notification EMEA/H/C/368/N/132
Updated with Decision(2013)9759 of 18/12/2013
14/05/2013 Centralised - Variation EMEA/H/C/368/IA/135
Updated with Decision(2013)9759 of 18/12/2013
28/06/2013 Centralised - Notification EMEA/H/C/368/N/134
Updated with Decision(2013)9759 of 18/12/2013
21/11/2013 Centralised - Notification EMEA/H/C/368/N/138
Updated with Decision(2013)9759 of 18/12/2013
23/12/2013 Centralised - 2-Monthly update EMEA/H/C/368/II/137/G (2013)9759 of 18/12/2013
24/01/2014 Centralised - 2-Monthly update EMEA/H/C/368/II/136 (2014)414 of 22/01/2014
02/04/2014 Centralised - Variation EMEA/H/C/368/II/145
Updated with Decision(2015)2321 of 30/03/2015
25/04/2014 Centralised - Variation EMEA/H/C/368/II/143
Updated with Decision(2015)2321 of 30/03/2015
20/11/2014 Centralised - Variation EMEA/H/C/368/II/147
Updated with Decision(2015)2321 of 30/03/2015
01/04/2015 Centralised - 2-Monthly update EMEA/H/C/368/II/148 (2015)2321 of 30/03/2015
24/07/2015 Centralised - Variation EMEA/H/C/368/IAin//G
17/09/2015 Centralised - Variation EMEA/H/C/368/II/151
21/12/2015 Centralised - Variation EMEA/H/C/368/IB/155
18/02/2016 Centralised - Variation EMEA/H/C/368/II/154
23/02/2016 Centralised - Variation EMEA/H/C/368/IG/660/G