Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Ifirmacombi   
Auth. number : EU/1/11/673
Active substance : 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: Krka d. d., Novo mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
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
8/03/2011 Centralised - Authorisation EMEA/H/C/2302 (2011)1603 of 4/03/2011
30/05/2012 Centralised - Variation EMEA/H/C/2302/IB/5
Updated with Decision(2012)7869 of 29/10/2012
27/07/2012 Centralised - Variation EMEA/H/C/2302/IB/7
Updated with Decision(2012)7869 of 29/10/2012
5/11/2012 Centralised - Variation (2012)7869 of 29/10/2012
3/06/2014 Centralised - Variation EMEA/H/C/2302/IB/12
Updated with Decision(2014)6369 of 04/09/2014
8/09/2014 Referral EMEA/H/C/2302/A-31/1370 (2014)6369 of 4/09/2014
5/12/2014 Centralised - Variation EMEA/H/C/2302/IB/13
Updated with Decision(2015)8303 of 19/11/2015
23/11/2015 Centralised - Renewal EMEA/H/C/2302/R/15 (2015)8303 of 19/11/2015
20/07/2017 Centralised - Variation EMEA/H/C/2302/IB/17
20/12/2017 Centralised - Variation EMEA/H/C/2302/IB/18