Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Irbesartan Teva   
Auth. number : EU/1/09/576
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: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

  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
04/11/2009 Centralised - Authorisation EMEA/H/C/1093 (2009)8603 of 30/10/2009
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1093/IA/2
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1093/IA/1
09/02/2010 Centralised - Variation EMEA/H/C/1093/IB/4
Updated with Decision(2011)692 of 01/02/2011
12/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1093/II/3
11/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1093/IA/5
11/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1093/IA/6
11/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1093/IA/7
08/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1093/IA/8/G
03/02/2011 Centralised - Variation (2011)692 of 01/02/2011
03/01/2012 Centralised - Variation EMEA/H/C/1093/IA/9/G
Updated with Decision(2012)3557 of 25/05/2012
03/05/2012 Centralised - Variation EMEA/H/C/1093/IA/10/G
Updated with Decision(2012)7763 of 25/10/2012
30/05/2012 Centralised - Variation (2012)3557 of 25/05/2012
22/07/2012 Centralised - Variation EMEA/H/C/1093/IB/11
Updated with Decision(2012)7763 of 25/10/2012
30/10/2012 Centralised - Variation (2012)7763 of 25/10/2012
12/02/2013 Corrigendum (2013)795 of 08/02/2013
20/01/2014 Centralised - Variation EMEA/H/C/1093/IB/18/G
Updated with Decision(2014)5263 of 18/07/2014
23/07/2014 Centralised - Renewal EMEA/H/C/1093/R/19 (2014)5263 of 18/07/2014
08/09/2014 Referral EMEA/H/C/1093/A-31/1370 (2014)6368 of 04/09/2014
17/09/2014 Centralised - Variation EMEA/H/C/1093/IAin/20/G
Updated with Decision(2014)9300 of 01/12/2014
03/12/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1093/T/22 (2014)9300 of 01/12/2014