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Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Irbesartan / Hydrochlorothiazide Teva   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Irbesartan / Hydrochlorothiazide Zentiva (BG)
   - Irbesartan / Hydrochlorothiazid Teva (CS)
   - Irbesartan / Hydrochlorthiazid Teva (DA)
   - Irbesartan / Hydrochlorothiazid (DE)
   - Irbesartán / Hidroclorotiazida Teva (ES)
   - Irbesartan / Idroclorotiazide Teva (IT)
   - Irbesartan / Hydrochloortiazide Teva (NL)
   - Irbesartan + Hidroclorotiazida Teva (PT)
   - Irbesartan / Hidroclorotiazidă Teva (RO)
   - Irbesartan / Hydrochlorothiazid Teva (SK)
   - Irbesartan / hidroklorotiazid Teva (SL)
Auth. number : EU/1/09/583
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.
This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone
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
01/12/2009 Centralised - Authorisation EMEA/H/C/1112 (2009)9600 of 26/11/2009
11/01/2010 Centralised - Variation EMEA/H/C/1112/IA/1
05/03/2010 Centralised - Variation EMEA/H/C/1112/IB/2
Updated with Decision(2010)7523 of 25/10/2010
12/05/2010 Centralised - Variation EMEA/H/C/1112/IB/3/G
Updated with Decision(2010)7523 of 25/10/2010
01/06/2010 Centralised - Variation EMEA/H/C/1112/IA/4/G
14/06/2010 Centralised - Variation EMEA/H/C/1112/IA/5/G
04/08/2010 Centralised - Variation EMEA/H/C/1112/IA/6
27/10/2010 Centralised - Variation (2010)7523 of 25/10/2010
07/02/2011 Centralised - Variation EMEA/H/C/1112/IA/7
21/09/2011 Centralised - Variation EMEA/H/C/1112/IA/8
Updated with Decision(2012)3207 of 10/05/2012
10/05/2012 Centralised - Variation EMEA/H/C/1112/IB/10
Updated with Decision(2012)7902 of 29/10/2012
14/05/2012 Centralised - Variation (2012)3207 of 10/05/2012
19/06/2012 Centralised - Variation EMEA/H/C/1112/IB/13
Updated with Decision(2012)7902 of 29/10/2012
19/06/2012 Centralised - Variation EMEA/H/C/1112/IB/12
Updated with Decision(2012)7902 of 29/10/2012
31/07/2012 Centralised - Variation EMEA/H/C/1112/IA/15/G
Updated with Decision(2012)7902 of 29/10/2012
01/11/2012 Centralised - Variation (2012)7902 of 29/10/2012
21/11/2012 Centralised - Variation EMEA/H/C/1112/IA/16/G
Updated with Decision(2013)9492 of 13/12/2013
27/06/2013 Centralised - Variation EMEA/H/C/1112/IB/20
Updated with Decision(2013)9492 of 13/12/2013
06/12/2013 Centralised - Variation EMEA/H/C/1112/IA/22
Updated with Decision(2014)6375 of 04/09/2014
18/12/2013 Centralised - Variation (2013)9492 of 13/12/2013
15/01/2014 Centralised - Variation EMEA/H/C/1112/IB/23/G
Updated with Decision(2014)6375 of 04/09/2014
08/09/2014 Referral EMEA/H/C/1112/A-31/1370 (2014)6375 of 04/09/2014