Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Karvezide   
Auth. number : EU/1/98/085
Active substance : Irbesartan / hydrochlorothiazide
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C09 - Agents acting on the renin-angiotensin system
Pharmacological subgroup: C09D - Angiotensin II antagonists, combinations
Chemical subgroup: C09DA - Angiotensin II antagonists and diuretics
Chemical substance: C09DA - Angiotensin II antagonists and diuretics
(See WHO ATC Index)
Indication: Treatment of essential hypertension.This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
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
21/10/1998 Centralised - Authorisation EMEA/H/C/221 (1998)3174 of 16/10/1998
13/05/1999 Centralised - Notification EMEA/H/C/221/N/5 (1999)1282 of 07/05/1999
09/02/2000 Centralised - Notification EMEA/H/C/221/N/9 (2000)174 of 03/02/2000
29/03/2000 Centralised - Notification EMEA/H/C/221/N/10 (2000)776 of 24/03/2000
22/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/9
20/11/2000 Centralised - Variation EMEA/H/C/221/II/12 (2000)3241 of 16/11/2000
23/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/13
25/04/2001 Centralised - Variation EMEA/H/C/221/II/14 (2001)843 of 23/04/2001
02/07/2001 Centralised - Variation EMEA/H/C/221/I/16 (2001)1377 of 29/06/2001
10/10/2001 Centralised - Variation EMEA/H/C/221/I/19, 20 (2001)2784 of 08/10/2001
22/02/2002 Centralised - Variation EMEA/H/C/221/I/21, 22, 23 (2002)651 of 19/02/2002
25/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/24
12/03/2002 Centralised - Variation EMEA/H/C/221/I/25 (2002)1030 of 08/03/2002
12/04/2002 Centralised - Variation EMEA/H/C/221/II/18 (2002)1437 of 10/04/2002
22/04/2002 Centralised - Variation EMEA/H/C/221/I/27 (2002)1556 of 18/04/2002
30/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/28
02/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/26
18/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/29
02/07/2002 Centralised - Notification EMEA/H/C/221/N/30 (2002)2564 of 28/06/2002
17/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/32
17/01/2003 Centralised - Notification EMEA/H/C/221/N/31 (2003)316 of 15/01/2003
10/03/2003 Centralised - Notification EMEA/H/C/221/N/33 (2003)806 of 07/03/2003
01/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/35
25/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/36
20/05/2003 Centralised - Notification EMEA/H/C/221/N/34 (2003)1703 of 16/05/2003
26/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/38
26/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/39
06/10/2003 Centralised - Variation EMEA/H/C/221/II/37 (2003)3571 of 02/10/2003
12/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/I/42
09/12/2003 Centralised - Renewal EMEA/H/C/221/R/41 (2003)4683 corr of 04/12/2003
04/03/2004 Centralised - Variation EMEA/H/C/221/X/40 (2004)735 of 02/03/2004
26/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/45
26/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/47
02/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/56
02/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/48
05/07/2004 Centralised - Variation EMEA/H/C/221/IA/50
Updated with Decision(2004)4307 of 28/10/2004
05/07/2004 Centralised - Variation EMEA/H/C/221/IA/49
Updated with Decision(2004)4307 of 28/10/2004
04/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/52
04/08/2004 Centralised - Variation EMEA/H/C/221/II/46 (2004)3052 of 02/08/2004
04/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/51
10/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/53
20/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/54
01/11/2004 Centralised - Variation EMEA/H/C/221/II/44 (2004)4307 of 28/10/2004
14/01/2005 Centralised - Variation EMEA/H/C/221/IB/55
Updated with Decision(2005)3492 of 08/09/2005
11/02/2005 Centralised - Variation EMEA/H/C/221/IA/56
Updated with Decision(2005)3492 of 08/09/2005
22/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/57
02/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/58
05/09/2005 Centralised - Variation EMEA/H/C/221/IA/59
Updated with Decision(2006)926 of 20/03/2006
13/09/2005 Centralised - Variation EMEA/H/C/221 (2005)3492 of 08/09/2005
14/09/2005 Centralised - Variation EMEA/H/C/221/IA/61
Updated with Decision(2006)926 of 20/03/2006
15/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/62
19/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/60
22/09/2005 Centralised - Variation EMEA/H/C/221/IA/63
Updated with Decision(2006)926 of 20/03/2006
29/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/64
29/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/65
15/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/67
29/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/68
17/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/70
20/01/2006 Centralised - Notification EMEA/H/C/221/N/72
Updated with Decision(2006)926 of 20/03/2006
06/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/II/69
22/03/2006 Centralised - Variation (2006)926 of 20/03/2006
30/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/73
22/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/76
23/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/77
29/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/75
11/07/2006 Centralised - Variation EMEA/H/C/221/IA/78
Updated with Decision(2007)114 of 11/01/2007
18/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/80
18/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/79
30/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/82
31/08/2006 Centralised - Variation EMEA/H/C/221/X/71 (2006)3953 of 28/08/2006
13/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/83
15/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/84
16/11/2006 Centralised - Notification EMEA/H/C/221/N/86
Updated with Decision(2007)114 of 11/01/2007
29/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/85
05/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/87
12/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/88
09/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/89
15/01/2007 Centralised - Variation EMEA/H/C/221/II/74 (2007)114 of 11/01/2007
16/01/2007 Centralised - Variation EMEA/H/C/221/IA/90
Updated with Decision(2007)5173 of 15/10/2007
16/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/101
23/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/97
28/03/2007 Centralised - Variation EMEA/H/C/221/IA/95
Updated with Decision(2007)5173 of 15/10/2007
28/03/2007 Centralised - Variation EMEA/H/C/221/IA/96
Updated with Decision(2007)5173 of 15/10/2007
28/03/2007 Centralised - Variation EMEA/H/C/221/IA/94
Updated with Decision(2007)5173 of 15/10/2007
28/03/2007 Centralised - Variation EMEA/H/C/221/IA/92
Updated with Decision(2007)5173 of 15/10/2007
28/03/2007 Centralised - Variation EMEA/H/C/221/IA/91
Updated with Decision(2007)5173 of 15/10/2007
28/03/2007 Centralised - Variation EMEA/H/C/221/IA/93
Updated with Decision(2007)5173 of 15/10/2007
25/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/99
07/06/2007 Centralised - Variation EMEA/H/C/221/IB/100
Updated with Decision(2007)5173 of 15/10/2007
07/06/2007 Centralised - Notification EMEA/H/C/221/N/98
Updated with Decision(2007)5173 of 15/10/2007
22/08/2007 Centralised - Notification EMEA/H/C/221/N/103
Updated with Decision(2008)1337 of 04/04/2008
23/08/2007 Centralised - Variation EMEA/H/C/221/IB/102
Updated with Decision(2008)1337 of 04/04/2008
21/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/104
28/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/105
18/10/2007 Centralised - Variation (2007)5173 of 15/10/2007
07/12/2007 Centralised - Notification EMEA/H/C/221/N/106
Updated with Decision(2008)1337 of 04/04/2008
15/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/107
13/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/108
03/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/110
09/04/2008 Centralised - Variation (2008)1337 of 04/04/2008
25/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/112
07/05/2008 Centralised - Variation EMEA/H/C/221/IB/113
Updated with Decision(2008)5705 of 01/10/2008
13/05/2008 Centralised - Variation EMEA/H/C/221/IB/111
Updated with Decision(2008)5705 of 01/10/2008
12/06/2008 Centralised - Variation EMEA/H/C/221/II/109 (2008)2730 of 10/06/2008
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/115
18/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/116
03/10/2008 Centralised - Renewal EMEA/H/C/221/R/114 (2008)5705 of 01/10/2008
02/03/2009 Centralised - Variation EMEA/H/C/221/II/117 (2009)1445 of 26/02/2009
01/04/2009 Centralised - Variation EMEA/H/C/221/II/118 (2009)2473 of 27/03/2009
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/119
22/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/121
12/06/2009 Centralised - Variation EMEA/H/C/221/IA/122
Updated with Decision(2009)10700 of 21/12/2009
24/06/2009 Centralised - Variation EMEA/H/C/221/IB/120
Updated with Decision(2009)10700 of 21/12/2009
02/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/123
08/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/124
05/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/II/125
23/10/2009 Centralised - Notification EMEA/H/C/221/N/126
Updated with Decision(2009)10700 of 21/12/2009
08/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/129
23/12/2009 Centralised - Variation EMEA/H/C/221/II/128 (2009)10700 of 21/12/2009
27/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/130
05/02/2010 Centralised - Variation EMEA/H/C/221/II/127 (2010)834 of 03/02/2010
06/04/2010 Centralised - Variation EMEA/H/C/221/IA/131/G
Updated with Decision(2010)5591 of 06/08/2010
29/04/2010 Centralised - Notification EMEA/H/C/221/N/132
Updated with Decision(2010)5591 of 06/08/2010
26/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/133
15/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IB/134
16/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/221/IA/135
10/08/2010 Centralised - Variation (2010)5591 of 06/08/2010
10/11/2010 Centralised - Variation EMEA/H/C/221/IA/136/G
Updated with Decision(2011)924 of 09/02/2011
11/02/2011 Centralised - Variation (2011)924 of 09/02/2011
07/04/2011 Centralised - Variation EMEA/H/C/221/IA/138
Updated with Decision(2011)3608 of 18/05/2011
23/05/2011 Centralised - Variation EMEA/H/C/221/WS/74 (2011)3608 of 18/05/2011
22/08/2011 Centralised - Variation EMEA/H/C/221/WS/147 (2011)6054 of 18/08/2011
24/10/2011 Centralised - Variation EMEA/H/C/221/WS/171 (2011)7673 of 20/10/2011
27/02/2012 Centralised - Variation EMEA/H/C/221/IB/147
Updated with Decision(2012)4519 of 27/06/2012
29/06/2012 Centralised - Variation EMEA/H/C/221/II/51 (2012)4519 of 27/06/2012
20/02/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/221/T/157 (2013)1021 of 18/02/2013
05/06/2013 Centralised - Variation EMEA/H/C/221/IA/164
Updated with Decision(2013)5129 of 31/07/2013
02/08/2013 Centralised - 2-Monthly update EMEA/H/C/221/II/158 (2013)5129 of 31/07/2013
19/02/2014 Centralised - Notification EMEA/H/C/221/N/168
Updated with Decision(2014)6362 of 04/09/2014
08/09/2014 Referral EMEA/H/A-31/1370/C/221/165 (2014)6362 of 04/09/2014
17/03/2015 Centralised - Notification EMEA/H/C/221/N/176