Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Irbesartan BMS
Auth. number : EU/1/06/375
INN : 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
Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

  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/786 (2007)201 of 19/01/2007
23/03/2007 Centralised - Variation EMEA/H/C/786/IA/2
23/03/2007 Centralised - Variation EMEA/H/C/786/IA/1
18/06/2007 Centralised - Variation EMEA/H/C/786/N/3
Updated with Decision(2008)2739 of 10/06/2008
21/09/2007 Centralised - Variation EMEA/H/C/786/IB/4
21/09/2007 Centralised - Variation EMEA/H/C/786/IA/5
14/12/2007 Centralised - Variation EMEA/H/C/786/IA/8
20/12/2007 Centralised - Variation EMEA/H/C/786/N/7
Updated with Decision(2008)2739 of 10/06/2008
21/12/2007 Centralised - Variation EMEA/H/C/786/IB/6
Updated with Decision(2008)2739 of 10/06/2008
13/02/2008 Centralised - Variation EMEA/H/C/786/IA/9
03/04/2008 Centralised - Variation EMEA/H/C/786/IA/11
25/04/2008 Centralised - Variation EMEA/H/C/786/IB/12
12/06/2008 Centralised - Variation EMEA/H/C/786/II/10 (2008)2739 of 10/06/2008
29/07/2008 Centralised - Variation EMEA/H/C/786/IA/14
05/08/2008 Centralised - Variation EMEA/H/C/786/N/13
Updated with Decision(2009)1579 of 02/03/2009
18/08/2008 Centralised - Variation EMEA/H/C/786/IB/15
04/03/2009 Centralised - Variation EMEA/H/C/786/II/16 (2009)1579 of 02/03/2009
25/03/2009 Centralised - Variation EMEA/H/C/786/II/37 (2009)2204 of 23/03/2009
09/04/2009 Centralised - Variation EMEA/H/C/786/II/18 (2009)2861 of 07/04/2009
21/04/2009 Centralised - Variation EMEA/H/C/786/IB/19
28/04/2009 Centralised - Variation EMEA/H/C/786/IA/20
22/06/2009 Centralised - Variation EMEA/H/C/786/IA/21
24/06/2009 Centralised - Variation EMEA/H/C/786/IA/22
29/09/2009 Centralised - Variation EMEA/H/C/786/II/23
13/11/2009 Centralised - Withdrawal (2009)9011 of 11/11/2009