Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Aprovel   
Auth. number : EU/1/97/046
Active substance : 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 (see section 5.1).
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
28/08/1997 Centralised - Authorisation EMEA/H/C/141 (97)2753 of 27/08/1997
01/03/1999 Centralised - Variation EMEA/H/C/141/I/10 (2000)1788 of 23/02/1999
15/04/1999 Centralised - Variation EMEA/H/C/141/II/8 (1999)934 of 13/04/1999
23/06/1999 Centralised - Variation EMEA/H/C/141/I/12 (1999)1632 of 16/06/1999
28/04/2000 Centralised - Variation EMEA/H/C/141/II/15 (2000)988 of 25/04/2000
22/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/16
16/11/2000 Centralised - Variation EMEA/H/C/141/II/17 (2000)3205 of 14/11/2000
23/11/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/19
17/01/2001 Centralised - Variation EMEA/H/C/141/I/18 (2001)5 of 15/01/2001
25/04/2001 Centralised - Variation EMEA/H/C/141/II/20 (2001)844 of 23/04/2001
10/10/2001 Centralised - Variation EMEA/H/C/141/I/24, 25 (2001)2787 of 08/10/2001
12/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/31
21/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/33
25/02/2002 Centralised - Variation EMEA/H/C/141/I/27, 28, 30 (2002)658 of 19/02/2002
12/03/2002 Centralised - Variation EMEA/H/C/141/I/34 (2002)1032 of 08/03/2002
12/04/2002 Centralised - Variation EMEA/H/C/141/II/23 (2002)1441 of 10/04/2002
15/04/2002 Centralised - Variation EMEA/H/C/141/I/32 (2002)1457 of 11/04/2002
30/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/36
02/05/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/35
14/06/2002 Centralised - Variation EMEA/H/C/141/II/29 (2002)2229 of 12/06/2002
18/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/38
05/11/2002 Centralised - Renewal EMEA/H/C/141/R/37 (2002)4384 of 29/10/2002
17/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/39
11/03/2003 Centralised - Notification EMEA/H/C/141/N/40 (2003)810 of 07/03/2003
01/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/42
29/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/43
17/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/45
17/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/44
30/07/2003 Centralised - Variation EMEA/H/C/141/II/41 (2003)2822 of 28/07/2003
12/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/I/47
23/12/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/49
04/03/2004 Centralised - Variation EMEA/H/C/141/X/46 (2004)734 of 02/03/2004
26/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/50
02/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/52
05/07/2004 Centralised - Variation EMEA/H/C/141/IA/54
Updated with Decision(2005)404 of 15/02/2005
05/07/2004 Centralised - Variation EMEA/H/C/141/IA/53
Updated with Decision(2005)404 of 15/02/2005
04/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/56
04/08/2004 Centralised - Variation EMEA/H/C/141/II/51 (2004)3051 of 02/08/2004
04/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/55
10/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/57
20/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/50
03/12/2004 Centralised - Notification EMEA/H/C/141/N/59
Updated with Decision(2005)404 of 15/02/2005
11/02/2005 Centralised - Variation EMEA/H/C/141/IA/60
Updated with Decision(2005)3550 of 13/09/2005
24/02/2005 Centralised - Variation (2005)404 of 15/02/2005
11/04/2005 Centralised - Variation EMEA/H/C/141/IB/61
Updated with Decision(2005)3550 of 13/09/2005
22/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/62
02/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/63
05/09/2005 Centralised - Variation EMEA/H/C/141/IA/64
Updated with Decision(2006)36 of 09/01/2006
14/09/2005 Centralised - Variation EMEA/H/C/141/IA/66
Updated with Decision(2006)36 of 09/01/2006
15/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/67
15/09/2005 Centralised - Variation (2005)3550 of 13/09/2005
16/09/2005 Centralised - Notification EMEA/H/C/141/N/69
Updated with Decision(2006)36 of 09/01/2006
19/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/65
29/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/70
15/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/71
29/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/72
11/01/2006 Centralised - Variation EMEA/H/C/141/II/68 (2006)36 of 09/01/2006
17/01/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/73
20/01/2006 Centralised - Notification EMEA/H/C/141/N/74
Updated with Decision(2006)2216 of 31/05/2006
30/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/76
05/04/2006 Corrigendum EMEA/H/C/141/II/68 (2006)36 corr of 03/04/2006
02/06/2006 Centralised - Variation EMEA/H/C/141/II/75, 77 (2006)2216 of 31/05/2006
22/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/79
22/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/76
23/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/80
29/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/78
11/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/82
11/07/2006 Centralised - Variation EMEA/H/C/141/IA/81
Updated with Decision(2007)828 of 06/03/2007
19/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/83
22/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/84
30/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/85
08/09/2006 Centralised - Notification EMEA/H/C/141/N/86
Updated with Decision(2007)828 of 06/03/2007
13/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/87
19/09/2006 Corrigendum EMEA/H/C/141/II/75, 77 (2006)2216 corr of 07/09/2006
15/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/88
29/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/89
05/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/90
09/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/91
25/01/2007 Centralised - Variation EMEA/H/C/141/IA/92
Updated with Decision(2007)4180 of 31/08/2007
08/03/2007 Centralised - Variation (2007)828 of 06/03/2007
21/03/2007 Centralised - Notification EMEA/H/C/141/N/94
Updated with Decision(2007)4180 of 31/08/2007
23/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/102
23/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/101
28/03/2007 Centralised - Variation EMEA/H/C/141/IA/100
Updated with Decision(2007)4180 of 31/08/2007
28/03/2007 Centralised - Variation EMEA/H/C/141/IA/99
Updated with Decision(2007)4180 of 31/08/2007
28/03/2007 Centralised - Variation EMEA/H/C/141/IA/98
Updated with Decision(2007)4180 of 31/08/2007
28/03/2007 Centralised - Variation EMEA/H/C/141/IA/97
Updated with Decision(2007)4180 of 31/08/2007
28/03/2007 Centralised - Variation EMEA/H/C/141/IA/96
Updated with Decision(2007)4180 of 31/08/2007
28/03/2007 Centralised - Variation EMEA/H/C/141/IA/95
Updated with Decision(2007)4180 of 31/08/2007
05/09/2007 Centralised - Renewal EMEA/H/C/141/R/93 (2007)4180 of 31/08/2007
21/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/103
21/12/2007 Centralised - Variation EMEA/H/C/141/IB/105
Updated with Decision(2008)2741 of 10/06/2008
15/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/107
15/01/2008 Centralised - Notification EMEA/H/C/141/N/106
Updated with Decision(2008)2741 of 10/06/2008
13/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/108
03/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/110
25/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/111
12/06/2008 Centralised - Variation EMEA/H/C/141/II/109 (2008)2741 of 10/06/2008
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/113
05/08/2008 Centralised - Notification EMEA/H/C/141/N/112
Updated with Decision(2009)1441 of 26/02/2009
18/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/113, 114
28/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/104
02/03/2009 Centralised - Variation EMEA/H/C/141/II/115 (2009)1441 of 26/02/2009
02/04/2009 Centralised - Variation EMEA/H/C/141/II/116 (2009)2607 of 31/03/2009
28/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/118
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/117
28/05/2009 Centralised - Notification EMEA/H/C/141/N/119
Updated with Decision(2010)5923 of 23/08/2010
02/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/120
10/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IA/121
07/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/II/122
08/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/123
12/04/2010 Centralised - Variation EMEA/H/C/141/IA/124/G
Updated with Decision(2010)5923 of 23/08/2010
12/04/2010 Centralised - Notification EMEA/H/C/141/N/125
Updated with Decision(2010)5923 of 23/08/2010
25/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/127
15/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/128
14/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IAin/129
24/08/2010 Centralised - Variation (2010)5923 of 23/08/2010
03/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/141/IB/130
02/11/2010 Centralised - Variation EMEA/H/C/141/II/126 (2010)7622 of 28/10/2010
03/11/2010 Centralised - Variation EMEA/H/C/141/IA/131/G
Updated with Decision(2011)979 of 11/02/2011
15/02/2011 Centralised - Variation (2011)979 of 11/02/2011
28/03/2011 Centralised - Variation EMEA/H/C/141/IA/134
Updated with Decision(2011)3723 of 23/05/2011
26/05/2011 Centralised - Variation EMEA/H/C/141/WS/74 (2011)3723 of 23/05/2011
23/06/2011 Centralised - Variation EMEA/H/C/141/II/132 (2011)4464 of 17/06/2011
13/04/2012 Centralised - Variation EMEA/H/C/141/IAin/142
Updated with Decision(2012)7215 of 10/10/2012
26/07/2012 Centralised - Variation EMEA/H/C/141/IA/143
Updated with Decision(2012)7215 of 10/10/2012
12/10/2012 Centralised - Variation (2012)7215 of 10/10/2012
05/06/2013 Centralised - Variation EMEA/H/C/141/IA/161
Updated with Decision(2013)5149 of 31/07/2013
05/08/2013 Centralised - 2-Monthly update EMEA/H/C/141/II/148 (2013)5149 of 31/07/2013
04/10/2013 Centralised - Variation EMEA/H/C/141/IG/331
Updated with Decision(2014)6356 of 04/09/2014
19/02/2014 Centralised - Notification EMEA/H/C/141/N/158
Updated with Decision(2014)6356 of 04/09/2014
08/09/2014 Referral EMEA/H/C/141/A-31 (2014)6356 of 04/09/2014
17/03/2015 Centralised - Notification EMEA/H/C/141/N-162