Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Irbesartan HCT BMS
Auth. number : EU/1/06/369
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: 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/784 (2007)198 of 19/01/2007
23/03/2007 Centralised - Variation EMEA/H/C/784/IA/1
16/05/2007 Centralised - Variation EMEA/H/C/784/IA/5
07/06/2007 Centralised - Variation EMEA/H/C/784/IB/4
Updated with Decision(2008)156 of 11/01/2008
01/07/2007 Centralised - Variation EMEA/H/C/784/N/2
Updated with Decision(2008)156 of 11/01/2008
23/08/2007 Centralised - Variation EMEA/H/C/784/IB/6
Updated with Decision(2008)156 of 11/01/2008
19/09/2007 Centralised - Variation EMEA/H/C/784/N/7
Updated with Decision(2008)156 of 11/01/2008
20/09/2007 Centralised - Variation EMEA/H/C/784/IA/9
21/09/2007 Centralised - Variation EMEA/H/C/784/IB/8
06/12/2007 Centralised - Variation EMEA/H/C/784/N/10
Updated with Decision(2008)156 of 11/01/2008
15/01/2008 Centralised - Variation (2008)156 of 11/01/2008
13/02/2008 Centralised - Variation EMEA/H/C/784/IA/12
03/04/2008 Centralised - Variation EMEA/H/C/784/IA/14
25/04/2008 Centralised - Variation EMEA/H/C/784/IB/16
07/05/2008 Centralised - Variation EMEA/H/C/784/IB/17
Updated with Decision(2008)15 of 05/01/2009
26/05/2008 Centralised - Variation EMEA/H/C/784/IB/15
Updated with Decision(2008)15 of 05/01/2009
12/06/2008 Centralised - Variation EMEA/H/C/784/II/13 (2008)2733 of 10/06/2008
29/07/2008 Centralised - Variation EMEA/H/C/784/IA/18
18/08/2008 Centralised - Variation EMEA/H/C/784/IB/19
07/01/2009 Centralised - Variation (2008)15 of 05/01/2009
26/02/2009 Centralised - Variation EMEA/H/C/784/II/20 (2009)1355 of 24/02/2009
20/03/2009 Centralised - Variation EMEA/H/C/784/II/21 (2009)2098 of 18/03/2009
09/04/2009 Centralised - Variation EMEA/H/C/784/II/22 (2009)2867 of 07/04/2009
21/04/2009 Centralised - Variation EMEA/H/C/784/IB/23
22/05/2009 Centralised - Variation EMEA/H/C/784/IA/25
22/06/2009 Centralised - Variation EMEA/H/C/784/IA/27
10/07/2009 Centralised - Variation EMEA/H/C/784/IA/28
13/11/2009 Centralised - Withdrawal (2009)9012 of 11/11/2009