Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: CoAprovel   
Auth. number : EU/1/98/086
INN : 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: C09DA04 - Irbesartan 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 Clir SNC
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
09/04/1999 Centralised - Variation EMEA/H/C/222/I/2 (1999)839 of 29/03/1999
29/03/2000 Centralised - Variation EMEA/H/C/222/N/10 (2000)775 of 24/03/2000
22/05/2000 Centralised - Variation EMEA/H/C/222/I/9
23/11/2000 Centralised - Variation EMEA/H/C/222/I/13
27/11/2000 Centralised - Variation EMEA/H/C/222/II/12 (2000)3240 of 16/11/2000
25/04/2001 Centralised - Variation EMEA/H/C/222/II/14 (2001)840 of 23/04/2001
02/07/2001 Centralised - Variation EMEA/H/C/222/I/16 (2001)1378 of 29/06/2001
10/10/2001 Centralised - Variation EMEA/H/C/222/I/19, 20 (2001)2788 of 08/10/2001
12/02/2002 Centralised - Variation EMEA/H/C/222/I/23
25/02/2002 Centralised - Variation EMEA/H/C/222/I/21, 22 (2002)661 of 19/02/2002
12/03/2002 Centralised - Variation EMEA/H/C/222/I/24 (2002)1028 of 08/03/2002
15/04/2002 Centralised - Variation EMEA/H/C/222/II/18 (2002)1449 of 11/04/2002
23/04/2002 Centralised - Variation EMEA/H/C/222/I/26 (2002)1567 of 19/04/2002
30/04/2002 Centralised - Variation EMEA/H/C/222/I/27
18/06/2002 Centralised - Variation EMEA/H/C/222/I/28
17/01/2003 Centralised - Variation EMEA/H/C/222/I/29
11/03/2003 Centralised - Variation EMEA/H/C/222/N/30 (2003)807 of 07/03/2003
01/04/2003 Centralised - Variation EMEA/H/C/222/I/31
29/04/2003 Centralised - Variation EMEA/H/C/222/I/32
26/06/2003 Centralised - Variation EMEA/H/C/222/I/34
26/06/2003 Centralised - Variation EMEA/H/C/222/I/35
06/10/2003 Centralised - Variation EMEA/H/C/222/II/33 (2003)3576 of 02/10/2003
19/10/2003 Centralised - Authorisation EMEA/H/C/222 (1998)3106 of 15/10/1998
12/11/2003 Centralised - Variation EMEA/H/C/222/I/38
09/12/2003 Centralised - Renewal EMEA/H/C/222/R/37 (2003)4686 corr of 04/12/2003
04/03/2004 Centralised - Variation EMEA/H/C/222/X/36 (2004)739 of 02/03/2004
26/04/2004 Centralised - Variation EMEA/H/C/222/IB/43
26/04/2004 Centralised - Variation EMEA/H/C/222/IB/41
02/07/2004 Centralised - Variation EMEA/H/C/222/IB/44
05/07/2004 Centralised - Variation EMEA/H/C/222/IA/45
Updated with Decision(2004)4306 of 28/10/2004
05/07/2004 Centralised - Variation EMEA/H/C/222/IA/46
Updated with Decision(2004)4306 of 28/10/2004
04/08/2004 Centralised - Variation EMEA/H/C/222/II/42 (2004)3049 of 02/08/2004
04/08/2004 Centralised - Variation EMEA/H/C/222/IB/47
04/08/2004 Centralised - Variation EMEA/H/C/222/IB/48
10/08/2004 Centralised - Variation EMEA/H/C/222/IB/49
20/09/2004 Centralised - Variation EMEA/H/C/222/IA/58
02/11/2004 Centralised - Variation EMEA/H/C/222/II/40 (2004)4306 of 28/10/2004
03/12/2004 Centralised - Variation EMEA/H/C/222/N/51
Updated with Decision(2005)3493 of 08/09/2005
14/01/2005 Centralised - Variation EMEA/H/C/222/IB/52
Updated with Decision(2005)3493 of 08/09/2005
11/02/2005 Centralised - Variation EMEA/H/C/222/IA/53
Updated with Decision(2005)3493 of 08/09/2005
12/07/2005 Corrigendum EMEA/H/C/222/II/40 (2004)4306 corr of 09/07/2005
22/08/2005 Centralised - Variation EMEA/H/C/222/IA/54
02/09/2005 Centralised - Variation EMEA/H/C/222/IB/55
05/09/2005 Centralised - Variation EMEA/H/C/222/IA/56
Updated with Decision(2006)925 of 20/03/2006
13/09/2005 Centralised - Variation EMEA/H/C/222 (2005)3493 of 08/09/2005
14/09/2005 Centralised - Variation EMEA/H/C/222/IA/58
Updated with Decision(2006)925 of 20/03/2006
15/09/2005 Centralised - Variation EMEA/H/C/222/IA/59
19/09/2005 Centralised - Variation EMEA/H/C/222/IB/57
29/09/2005 Centralised - Variation EMEA/H/C/222/IA/60
29/09/2005 Centralised - Variation EMEA/H/C/222/IA/61
15/11/2005 Centralised - Variation EMEA/H/C/222/IB/62
29/11/2005 Centralised - Variation EMEA/H/C/222/IB/63
17/01/2006 Centralised - Variation EMEA/H/C/222/IB/65
20/01/2006 Centralised - Variation EMEA/H/C/222/N/67
Updated with Decision(2006)925 of 20/03/2006
06/02/2006 Centralised - Variation EMEA/H/C/222/II/64
22/03/2006 Centralised - Variation (2006)925 of 20/03/2006
30/03/2006 Centralised - Variation EMEA/H/C/222/IB/68
22/06/2006 Centralised - Variation EMEA/H/C/222/IA/71
23/06/2006 Centralised - Variation EMEA/H/C/222/IA/72
29/06/2006 Centralised - Variation EMEA/H/C/222/IB/70
11/07/2006 Centralised - Variation EMEA/H/C/222/IA/73
Updated with Decision(2007)115 of 11/01/2007
18/07/2006 Centralised - Variation EMEA/H/C/222/IA/74
18/07/2006 Centralised - Variation EMEA/H/C/222/IA/75
22/08/2006 Centralised - Variation EMEA/H/C/222/IB/76
30/08/2006 Centralised - Variation EMEA/H/C/222/IA/77
31/08/2006 Centralised - Variation EMEA/H/C/222/X/66 (2006)3959 of 28/08/2006
13/09/2006 Centralised - Variation EMEA/H/C/222/IA/78
15/11/2006 Centralised - Variation EMEA/H/C/222/IB/79
29/11/2006 Centralised - Variation EMEA/H/C/222/IB/80
05/12/2006 Centralised - Variation EMEA/H/C/222/IA/81
12/12/2006 Centralised - Variation EMEA/H/C/222/IA/82
09/01/2007 Centralised - Variation EMEA/H/C/222/IA/83
15/01/2007 Centralised - Variation EMEA/H/C/222/II/69 (2007)115 of 11/01/2007
16/01/2007 Centralised - Variation EMEA/H/C/222/IA/84
Updated with Decision(2007)5154 of 15/10/2007
21/03/2007 Centralised - Variation EMEA/H/C/222/IA/N/85
Updated with Decision(2007)5154 of 15/10/2007
28/03/2007 Centralised - Variation EMEA/H/C/222/IA/87
Updated with Decision(2007)5154 of 15/10/2007
28/03/2007 Centralised - Variation EMEA/H/C/222/IA/86
Updated with Decision(2007)5154 of 15/10/2007
28/03/2007 Centralised - Variation EMEA/H/C/222/IA/88
Updated with Decision(2007)5154 of 15/10/2007
28/03/2007 Centralised - Variation EMEA/H/C/222/IA/91
Updated with Decision(2007)5154 of 15/10/2007
28/03/2007 Centralised - Variation EMEA/H/C/222/IA/90
Updated with Decision(2007)5154 of 15/10/2007
28/03/2007 Centralised - Variation EMEA/H/C/222/IA/89
Updated with Decision(2007)5154 of 15/10/2007
16/05/2007 Centralised - Variation EMEA/H/C/222/IA/95
25/05/2007 Centralised - Variation EMEA/H/C/222/IB/93
07/06/2007 Centralised - Variation EMEA/H/C/222/IB/94
Updated with Decision(2007)5154 of 15/10/2007
22/08/2007 Centralised - Variation EMEA/H/C/222/N/97
Updated with Decision(2008)1352 of 04/04/2008
23/08/2007 Centralised - Variation EMEA/H/C/222/IB/96
Updated with Decision(2008)1352 of 04/04/2008
21/09/2007 Centralised - Variation EMEA/H/C/222/IB/98
23/10/2007 Centralised - Variation (2007)5154 of 15/10/2007
11/12/2007 Centralised - Variation EMEA/H/C/222/N/100
Updated with Decision(2008)1352 of 04/04/2008
15/01/2008 Centralised - Variation EMEA/H/C/222/IA/101
13/02/2008 Centralised - Variation EMEA/H/C/222/IA/102
03/04/2008 Centralised - Variation EMEA/H/C/222/IA/104
09/04/2008 Centralised - Variation (2008)1352 of 04/04/2008
25/04/2008 Centralised - Variation EMEA/H/C/222/IB/106
07/05/2008 Centralised - Variation EMEA/H/C/222/IB/107
Updated with Decision(2008)5706 of 01/10/2008
13/05/2008 Centralised - Variation EMEA/H/C/222/IB/105
Updated with Decision(2008)5706 of 01/10/2008
12/06/2008 Centralised - Variation EMEA/H/C/222/II/103 (2008)2731 of 10/06/2008
29/07/2008 Centralised - Variation EMEA/H/C/222/IA/109
18/08/2008 Centralised - Variation EMEA/H/C/222/IB/110
28/09/2008 Centralised - Variation EMEA/H/C/222/IA/99
03/10/2008 Centralised - Renewal EMEA/H/C/222/R/108 (2008)5706 of 01/10/2008
02/03/2009 Centralised - Variation EMEA/H/C/222/II/111 (2009)1443 of 26/02/2009
02/04/2009 Centralised - Variation EMEA/H/C/222/II/112 (2009)2605 of 31/03/2009
14/05/2009 Centralised - Variation EMEA/H/C/222/IB/113
22/05/2009 Centralised - Variation EMEA/H/C/222/IA/116
28/05/2009 Centralised - Variation EMEA/H/C/222/N/114
Updated with Decision(2010)95 of 11/01/2010
11/06/2009 Centralised - Variation EMEA/H/C/222/IA/117
Updated with Decision(2010)95 of 11/01/2010
24/06/2009 Centralised - Variation EMEA/H/C/222/IB/115
Updated with Decision(2010)95 of 11/01/2010
02/07/2009 Centralised - Variation EMEA/H/C/222/IA/118
10/07/2009 Centralised - Variation EMEA/H/C/222/IA/119
07/10/2009 Centralised - Variation EMEA/H/C/222/II/120
20/10/2009 Centralised - Variation EMEA/H/C/222/N/121
Updated with Decision(2010)95 of 11/01/2010
08/12/2009 Centralised - Variation EMEA/H/C/222/IB/124
06/01/2010 Centralised - Variation EMEA/H/C/222/IB/125
13/01/2010 Centralised - Variation EMEA/H/C/222/II/123 (2010)95 of 11/01/2010
05/02/2010 Centralised - Variation EMEA/H/C/222/II/122 (2010)833 of 03/02/2010
12/04/2010 Centralised - Variation EMEA/H/C/222/IA/126/G
Updated with Decision(2010)5924 of 23/08/2010
29/04/2010 Centralised - Variation EMEA/H/C/222/N/127
Updated with Decision(2010)5924 of 23/08/2010
25/05/2010 Centralised - Variation EMEA/H/C/222/IB/128
15/06/2010 Centralised - Variation EMEA/H/C/222/IB/129
14/07/2010 Centralised - Variation EMEA/H/C/222/IA/130
24/08/2010 Centralised - Variation (2010)5924 of 23/08/2010
03/11/2010 Centralised - Variation EMEA/H/C/222/IA/131/G
Updated with Decision(2011)983 of 11/02/2011
15/02/2011 Centralised - Variation (2011)983 of 11/02/2011
26/02/2011 Centralised - Variation EMEA/H/C/222/IA/132
28/03/2011 Centralised - Variation EMEA/H/C/222/IA/134
Updated with Decision(2011)3721 of 23/05/2011
30/05/2011 Centralised - Variation EMEA/H/C/222/WS/74 (2011)3721 of 23/05/2011
06/09/2011 Centralised - Variation EMEA/H/C/222/WS/147 (2011)6342 of 02/09/2011
26/10/2011 Centralised - Variation EMEA/H/C/222/WS/171 (2011)7803 of 24/10/2011
14/12/2011 Centralised - Variation EMEA/H/C/222/IA/143/G
Updated with Decision(2012)3212 of 10/05/2012
23/02/2012 Centralised - Variation EMEA/H/C/222/IB/144
Updated with Decision(2012)3212 of 10/05/2012
13/04/2012 Centralised - Variation EMEA/H/C/222/IA/149
Updated with Decision(2012)4600 of 28/06/2012
14/05/2012 Centralised - Variation (2012)3212 of 10/05/2012
03/07/2012 Centralised - Variation EMEA/H/C/222/II/148 (2012)4600 of 28/06/2012
05/06/2013 Centralised - Variation EMEA/H/C/222/IA/161
Updated with Decision(2013)5151 of 31/07/2013
05/08/2013 Centralised - Variation EMEA/H/C/222/II/155 (2013)5151 of 31/07/2013
04/10/2013 Centralised - Variation EMEA/H/C/222/IG/331
19/02/2014 Centralised - Variation EMEA/H/C/222/N/166