Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Irbesartan HCT Zentiva   
Auth. number : EU/1/06/377
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.
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/783 (2007)200 of 19/01/2007
23/03/2007 Centralised - Variation EMEA/H/C/783/IA/3
15/05/2007 Centralised - Variation EMEA/H/C/783/N/1
Updated with Decision(2008)420 of 28/01/2008
16/05/2007 Centralised - Variation EMEA/H/C/783/IA/6
25/05/2007 Centralised - Variation EMEA/H/C/783/IB/4
07/06/2007 Centralised - Variation EMEA/H/C/783/IB/5
Updated with Decision(2008)420 of 28/01/2008
19/07/2007 Centralised - Variation EMEA/H/C/783/N/8
Updated with Decision(2008)420 of 28/01/2008
23/08/2007 Centralised - Variation EMEA/H/C/783/IB/7
Updated with Decision(2008)420 of 28/01/2008
20/09/2007 Centralised - Variation EMEA/H/C/783/IA/10
21/09/2007 Centralised - Variation EMEA/H/C/783/IB/9
11/12/2007 Centralised - Variation EMEA/H/C/783/N/11
Updated with Decision(2008)420 of 28/01/2008
14/12/2007 Centralised - Variation EMEA/H/C/783/IA/12
30/01/2008 Centralised - Variation (2008)420 of 28/01/2008
13/02/2008 Centralised - Variation EMEA/H/C/783/IA/13
03/04/2008 Centralised - Variation EMEA/H/C/783/IA/15
25/04/2008 Centralised - Variation EMEA/H/C/783/IB/17
07/05/2008 Centralised - Variation EMEA/H/C/783/IB/18
Updated with Decision(2009)55 of 07/01/2009
15/05/2008 Centralised - Variation EMEA/H/C/783/IB/16
Updated with Decision(2009)55 of 07/01/2009
12/06/2008 Centralised - Variation EMEA/H/C/783/II/14 (2008)2738 of 10/06/2008
29/07/2008 Centralised - Variation EMEA/H/C/783/IA/19
18/08/2008 Centralised - Variation EMEA/H/C/783/IB/20
09/01/2009 Centralised - Variation (2009)55 of 07/01/2009
10/03/2009 Centralised - Variation EMEA/H/C/783/II/21 (2009)1717 of 06/03/2009
01/04/2009 Centralised - Variation EMEA/H/C/783/II/22 (2009)2472 of 27/03/2009
21/04/2009 Centralised - Variation EMEA/H/C/783/II/23 (2009)3062 of 17/04/2009
21/04/2009 Centralised - Variation EMEA/H/C/783/IB/24
22/05/2009 Centralised - Variation EMEA/H/C/783/IA/27
28/05/2009 Centralised - Variation EMEA/H/C/783/N/25
Updated with Decision(2009)10708 of 21/12/2009
12/06/2009 Centralised - Variation EMEA/H/C/783/IA/28
Updated with Decision(2009)10708 of 21/12/2009
22/06/2009 Centralised - Variation EMEA/H/C/783/IA/29
24/06/2009 Centralised - Variation EMEA/H/C/783/IB/26
Updated with Decision(2009)10708 of 21/12/2009
10/07/2009 Centralised - Variation EMEA/H/C/783/IA/30
08/10/2009 Centralised - Variation EMEA/H/C/783/II/31
16/11/2009 Centralised - Variation EMEA/H/C/783/N/32
Updated with Decision(2009)10708 of 21/12/2009
03/12/2009 Centralised - Variation EMEA/H/C/783/IB/35
23/12/2009 Centralised - Variation EMEA/H/C/783/II/34 (2009)10708 of 21/12/2009
07/01/2010 Centralised - Variation EMEA/H/C/783/IB/36
08/02/2010 Centralised - Variation EMEA/H/C/783/II/33 (2010)865 of 04/02/2010
04/05/2010 Centralised - Variation EMEA/H/C/783/N/38
Updated with Decision(2011)78 of 06/01/2011
21/05/2010 Centralised - Variation EMEA/H/C/783/IB/39
28/05/2010 Centralised - Variation EMEA/H/C/783/IA/37/G (2010)3490 of 26/05/2010
Updated with Decision(2010)3490 of 26/05/2010
10/06/2010 Centralised - Variation EMEA/H/C/783/IB/40
13/07/2010 Centralised - Variation EMEA/H/C/783/IA/41
28/10/2010 Centralised - Variation EMEA/H/C/783/IA/42/G
Updated with Decision(2011)78 of 06/01/2011
11/01/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/783/T/43 (2011)78 of 06/01/2011
11/04/2011 Centralised - Variation EMEA/H/C/783/IA/45
Updated with Decision(2011)6418 of 07/09/2011
21/06/2011 Centralised - Variation EMEA/H/C/783/WS/74 (2011)4404 of 16/06/2011
09/09/2011 Centralised - Variation EMEA/H/C/783/WS/147 (2011)6418 of 07/09/2011
26/10/2011 Centralised - Variation EMEA/H/C/783/WS/171 (2011)7790 of 24/10/2011
01/03/2012 Centralised - Renewal EMEA/H/C/783/R/49 (2012)1372 of 27/02/2012
03/07/2012 Centralised - Variation EMEA/H/C/783/II/60 (2012)4496 of 27/06/2012
12/11/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/783/T/63 (2012)8375 of 12/11/2012
05/06/2013 Centralised - Variation EMEA/H/C/783/IA/76
Updated with Decision(2013)5135 of 31/07/2013
02/08/2013 Centralised - Variation EMEA/H/C/783/II/69 (2013)5135 of 31/07/2013
12/03/2014 Centralised - Variation EMEA/H/C/783/N/79
Updated with Decision(2014)6390 of 04/09/2014
08/09/2014 Referral EMEA/H/C/783/A-31/1370 (2014)6390 of 04/09/2014