Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Karvea   
Auth. number : EU/1/97/049
INN : Irbesartan
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C09 - Agents acting on the renin-angiotensin system
Pharmacological subgroup: C09C - Angiotensin II antagonists, plain
Chemical subgroup: C09CA - Angiotensin II antagonists, plain
Chemical substance: C09CA04 - Irbesartan
(See WHO ATC Index)
Indication: Treatment of essential hypertension.Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Marketing Authorisation Holder: Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France

  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
28/08/1997 Centralised - Authorisation EMEA/H/C/142 (97)2754 of 27/08/1997
15/04/1999 Centralised - Variation EMEA/H/C/142/II/8 (1999)935 of 13/04/1999
23/06/1999 Centralised - Variation EMEA/H/C/142/I/11 (1999)1629 of 16/06/1999
08/05/2000 Centralised - Variation EMEA/H/C/142/II/14 (2000)1187 of 03/05/2000
22/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/15
03/08/2000 Centralised - Notification EMEA/H/C/142/N/16 (2000)2330 of 27/07/2000
20/11/2000 Centralised - Variation EMEA/H/C/142/II/17 (2000)3208 of 16/11/2000
23/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/19
17/01/2001 Centralised - Variation EMEA/H/C/142/I/18 (2001)7 of 15/01/2001
25/04/2001 Centralised - Variation EMEA/H/C/142/II/20 (2001)841 of 23/04/2001
10/10/2001 Centralised - Variation EMEA/H/C/142/I/24, 26 (2001)2783 of 08/10/2001
21/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/34
22/02/2002 Centralised - Variation EMEA/H/C/142/I/27, 28, 30 (2002)653 of 19/02/2002
25/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/32
12/03/2002 Centralised - Variation EMEA/H/C/142/I/35 (2002)1031 of 08/03/2002
12/04/2002 Centralised - Variation EMEA/H/C/142/II/23 (2002)1438 of 10/04/2002
16/04/2002 Centralised - Variation EMEA/H/C/142/I/33 (2002)1488 of 12/04/2002
30/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/37
02/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/36
14/06/2002 Centralised - Variation EMEA/H/C/142/II/29 (2002)2230 of 12/06/2002
18/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/39
04/07/2002 Centralised - Notification EMEA/H/C/142/N/40 (2002)2556 of 28/06/2002
05/11/2002 Centralised - Renewal EMEA/H/C/142/R/38 (2002)4386 of 29/10/2002
17/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/42
20/01/2003 Centralised - Notification EMEA/H/C/142/N/41 (2003)332 of 16/01/2003
11/03/2003 Centralised - Notification EMEA/H/C/142/N/43 (2003)809 of 07/03/2003
01/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/46
25/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/47
22/05/2003 Centralised - Notification EMEA/H/C/142/N/45 (2003)1719 of 19/05/2003
19/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/48
19/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/49
01/08/2003 Centralised - Variation EMEA/H/C/142/II/44 (2003)2844 of 30/07/2003
12/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/I/51
23/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/53
04/03/2004 Centralised - Variation EMEA/H/C/142/X/50 (2004)741 of 02/03/2004
26/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/54
05/07/2004 Centralised - Variation EMEA/H/C/142/IA/57
Updated with Decision(2005)403 of 15/02/2005
05/07/2004 Centralised - Variation EMEA/H/C/142/IA/58
Updated with Decision(2005)403 of 15/02/2005
04/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/59
04/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/60
04/08/2004 Centralised - Variation EMEA/H/C/142/II/55 (2004)3053 of 02/08/2004
10/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/61
20/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/62
11/02/2005 Centralised - Variation EMEA/H/C/142/IA/63
Updated with Decision(2005)3546 of 13/09/2005
17/02/2005 Centralised - Variation (2005)403 of 15/02/2005
11/04/2005 Centralised - Variation EMEA/H/C/142/IB/64
Updated with Decision(2005)3546 of 13/09/2005
22/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/65
02/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/66
05/09/2005 Centralised - Variation EMEA/H/C/142/IA/67
Updated with Decision(2006)35 of 09/01/2006
14/09/2005 Centralised - Variation EMEA/H/C/142/IA/69
Updated with Decision(2006)35 of 09/01/2006
15/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/70
15/09/2005 Centralised - Variation (2005)3546 of 13/09/2005
16/09/2005 Centralised - Notification EMEA/H/C/142/N/72
Updated with Decision(2006)35 of 09/01/2006
19/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/68
22/09/2005 Centralised - Variation EMEA/H/C/142/IA/73
Updated with Decision(2006)35 of 09/01/2006
29/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/74
15/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/76
29/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/77
11/01/2006 Centralised - Variation EMEA/H/C/142/II/71 (2006)35 of 09/01/2006
17/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/78
20/01/2006 Centralised - Notification EMEA/H/C/142/N/79
Updated with Decision(2006)2304 of 08/06/2006
30/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/81
12/06/2006 Centralised - Variation EMEA/H/C/142/II/80, 82 (2006)2304 of 08/06/2006
22/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/84
23/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/85
29/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/83
11/07/2006 Centralised - Variation EMEA/H/C/142/IA/86
Updated with Decision(2007)829 of 06/03/2007
19/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/88
19/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/87
22/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/89
22/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/81
30/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/90
13/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/91
15/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/92
16/11/2006 Centralised - Notification EMEA/H/C/142/N/94
Updated with Decision(2007)829 of 06/03/2007
29/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/93
05/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/95
09/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/96
25/01/2007 Centralised - Variation EMEA/H/C/142/IA/97
Updated with Decision(2007)4170 of 31/08/2007
08/03/2007 Centralised - Variation (2007)829 of 06/03/2007
23/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/105
23/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/106
28/03/2007 Centralised - Variation EMEA/H/C/142/IA/102
Updated with Decision(2007)4170 of 31/08/2007
28/03/2007 Centralised - Variation EMEA/H/C/142/IA/101
Updated with Decision(2007)4170 of 31/08/2007
28/03/2007 Centralised - Variation EMEA/H/C/142/IA/100
Updated with Decision(2007)4170 of 31/08/2007
28/03/2007 Centralised - Variation EMEA/H/C/142/IA/99
Updated with Decision(2007)4170 of 31/08/2007
28/03/2007 Centralised - Variation EMEA/H/C/142/IA/104
Updated with Decision(2007)4170 of 31/08/2007
28/03/2007 Centralised - Variation EMEA/H/C/142/IA/103
Updated with Decision(2007)4170 of 31/08/2007
15/05/2007 Corrigendum (2007)829 corr of 11/05/2007
18/06/2007 Centralised - Notification EMEA/H/C/142/N/107
Updated with Decision(2007)4170 of 31/08/2007
06/09/2007 Centralised - Renewal EMEA/H/C/142/R/98 (2007)4170 of 31/08/2007
21/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/108
28/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/109
21/12/2007 Centralised - Variation EMEA/H/C/142/IB/110
Updated with Decision(2008)2736 of 10/06/2008
15/01/2008 Centralised - Notification EMEA/H/C/142/N/111
Updated with Decision(2008)2736 of 10/06/2008
15/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/112
13/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/113
03/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/115
25/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/116
12/06/2008 Other procedure - Archives (2008)2736 of 10/06/2008
12/06/2008 Centralised - Variation EMEA/H/C/142/II/114 (2008)2736 of 10/06/2008
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/118
05/08/2008 Centralised - Notification EMEA/H/C/142/N/117
Updated with Decision(2009)1444 of 26/02/2009
18/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/119
02/03/2009 Centralised - Variation EMEA/H/C/142/II/120 (2009)1444 of 26/02/2009
02/04/2009 Centralised - Variation EMEA/H/C/142/II/121 (2009)2606 of 31/03/2009
28/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/123
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/122
02/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/124
08/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/125
05/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/II/126
08/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/127
06/04/2010 Centralised - Notification EMEA/H/C/142/N/129
Updated with Decision(2010)5590 of 06/08/2010
06/04/2010 Centralised - Variation EMEA/H/C/142/IA/128/G
Updated with Decision(2010)5590 of 06/08/2010
26/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/131
15/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/132
16/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IA/133
10/08/2010 Centralised - Variation (2010)5590 of 06/08/2010
30/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/142/IB/134
27/10/2010 Centralised - Variation EMEA/H/C/142/II/130 (2010)7539 of 25/10/2010
10/11/2010 Centralised - Variation EMEA/H/C/142/IA/135/G
Updated with Decision(2011)410 of 21/01/2011
26/01/2011 Centralised - Variation (2011)410 of 21/01/2011
07/04/2011 Centralised - Variation EMEA/H/C/142/IA/138
Updated with Decision(2011)3607 of 18/05/2011
23/05/2011 Centralised - Variation EMEA/H/C/142/WS/74 (2011)3607 of 18/05/2011
05/07/2011 Centralised - Variation EMEA/H/C/142/II/136 (2011)4835 of 29/06/2011
26/07/2012 Centralised - Variation EMEA/H/C/142/IA/147
Updated with Decision(2012)7208 of 10/10/2012
12/10/2012 Centralised - Variation (2012)7208 of 10/10/2012
20/02/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/142/T/152 (2013)1020 of 18/02/2013
05/06/2013 Centralised - Variation EMEA/H/C/142/IA/158
Updated with Decision(2013)5128 of 31/07/2013
02/08/2013 Centralised - 2-Monthly update EMEA/H/C/142/II/153 (2013)5128 of 31/07/2013
19/02/2014 Centralised - Notification EMEA/H/C/142/N/162
Updated with Decision(2014)6361 of 04/09/2014
08/09/2014 Referral EMEA/H/A-31/1370/C/142/159 (2014)6361 of 04/09/2014