Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Irbesartan Zentiva   
Auth. number : EU/1/06/376
INN : Irbesartan
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: Irbesartan Zentiva is indicated in adults for the treatment of essential hypertension.
It is also indicated for the treatment of renal disease in adult 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
23/01/2007 Centralised - Authorisation EMEA/H/C/785 (2007)199 of 19/01/2007
23/03/2007 Centralised - Variation EMEA/H/C/785/IA/3
23/03/2007 Centralised - Variation EMEA/H/C/785/IA/2
15/05/2007 Centralised - Variation EMEA/H/C/785/N/1
Updated with Decision(2008)2792 of 11/06/2008
20/09/2007 Centralised - Variation EMEA/H/C/785/IA/5
25/09/2007 Centralised - Variation EMEA/H/C/785/IB/4
20/12/2007 Centralised - Variation EMEA/H/C/785/IA/8
21/12/2007 Centralised - Variation EMEA/H/C/785/IB/6
Updated with Decision(2008)2792 of 11/06/2008
04/01/2008 Centralised - Variation EMEA/H/C/785/N/7
Updated with Decision(2008)2792 of 11/06/2008
13/02/2008 Centralised - Variation EMEA/H/C/785/IA/9
03/04/2008 Centralised - Variation EMEA/H/C/785/IA/11
25/04/2008 Centralised - Variation EMEA/H/C/785/IB/12
13/06/2008 Centralised - Variation EMEA/H/C/785/II/10 (2008)2792 of 11/06/2008
29/07/2008 Centralised - Variation EMEA/H/C/785/IA/14
05/08/2008 Centralised - Variation EMEA/H/C/785/N/13
Updated with Decision(2009)1385 of 25/02/2009
18/08/2008 Centralised - Variation EMEA/H/C/785/IB/15
27/02/2009 Centralised - Variation EMEA/H/C/785/II/16 (2009)1385 of 25/02/2009
19/03/2009 Centralised - Variation EMEA/H/C/785/II/17 (2009)2069 of 17/03/2009
15/04/2009 Centralised - Variation EMEA/H/C/785/II/18 (2009)2909 of 08/04/2009
21/04/2009 Centralised - Variation EMEA/H/C/785/IB/19
30/04/2009 Centralised - Variation EMEA/H/C/785/IA/20
19/05/2009 Centralised - Variation EMEA/H/C/785/N/21
Updated with Decision(2010)3214 of 12/05/2010
22/06/2009 Centralised - Variation EMEA/H/C/785/IA/22
10/07/2009 Centralised - Variation EMEA/H/C/785/IA/23
05/10/2009 Centralised - Variation EMEA/H/C/785/II/24
03/12/2009 Centralised - Variation EMEA/H/C/785/IB/25
31/03/2010 Centralised - Variation EMEA/H/C/785/N/27
Updated with Decision(2010)3214 of 12/05/2010
18/05/2010 Centralised - Variation EMEA/H/C/785/IA/26/G (2010)3214 of 12/05/2010
Updated with Decision(2010)3214 of 12/05/2010
08/06/2010 Centralised - Variation EMEA/H/C/785/IB/29
10/06/2010 Centralised - Variation EMEA/H/C/785/IB/30
06/08/2010 Centralised - Variation EMEA/H/C/785/IA/31
14/10/2010 Centralised - Variation EMEA/H/C/785/IB/32
03/11/2010 Centralised - Variation EMEA/H/C/785/IA/33/G
Updated with Decision(2011)76 of 06/01/2011
09/11/2010 Centralised - Variation EMEA/H/C/785/II/28 (2010)7828 of 05/11/2010
11/01/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/785/T/34 (2011)76 of 06/01/2011
15/04/2011 Centralised - Variation EMEA/H/C/785/IA/37
Updated with Decision(2011)4170 of 07/06/2011
09/06/2011 Centralised - Variation EMEA/H/C/785/IB/WS/74 (2011)4170 of 07/06/2011
07/07/2011 Centralised - Variation EMEA/H/C/785/II/35 (2011)4991 of 05/07/2011
24/01/2012 Centralised - Renewal EMEA/H/C/785/R/41 (2012)409 of 20/01/2012
08/02/2012 Centralised - Variation EMEA/H/C/785/IA/46/G
Updated with Decision(2012)6139 of 30/08/2012
03/04/2012 Centralised - Variation EMEA/H/C/785/IA/49
Updated with Decision(2012)6139 of 30/08/2012
29/05/2012 Centralised - Variation EMEA/H/C/785/N/48
Updated with Decision(2012)6139 of 30/08/2012
26/07/2012 Centralised - Variation EMEA/H/C/785/IA/50
Updated with Decision(2012)6139 of 30/08/2012
03/09/2012 Centralised - Variation (2012)6139 of 30/08/2012
03/10/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/785/T/51 (2012)6959 of 28/09/2012
06/03/2013 Corrigendum (2013)1323 of 04/03/2013
05/06/2013 Centralised - Variation EMEA/H/C/785/IA/62
Updated with Decision(2013)5152 of 31/07/2013
05/08/2013 Centralised - Variation EMEA/H/C/785/II/57 (2013)5152 of 31/07/2013
12/03/2014 Centralised - Variation EMEA/H/C/785/N/66