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- Irbesartan Zentiva
Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Irbesartan Zentiva
|
| Auth. number : | EU/1/06/376 |
| INN : | Irbesartan |
| ATC: | C - Cardiovascular system C09 - Agents acting on the renin-angiotensin system C09D - Angiotensin II antagonists, combinations C09DA - Angiotensin II antagonists and diuretics C09DA04 - Irbesartan and diuretics (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 |
| Marketing Authorisation Holder: | Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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/2 | ||||
| 23/03/2007 | Centralised - Variation | EMEA/H/C/785/IA/3 | ||||
| 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 |