Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ifirmasta   
Auth. number : EU/1/08/480
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: 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
03/12/2008 Centralised - Authorisation EMEA/H/C/962 (2008)7923 of 01/12/2008
01/09/2009 Centralised - Variation EMEA/H/C/962/II/1 (2009)6730 of 28/08/2009
24/09/2009 Centralised - Variation EMEA/H/C/962/IB/2
Updated with Decision(2010)2579 of 19/04/2010
23/04/2010 Centralised - Variation (2010)2579 of 19/04/2010
04/01/2011 Centralised - Variation EMEA/H/C/962/II/3/G
01/02/2011 Centralised - Variation EMEA/H/C/962/IB/4
Updated with Decision(2011)6641 of 19/09/2011
22/09/2011 Centralised - Variation (2011)6641 of 19/09/2011
14/03/2012 Centralised - Variation EMEA/H/C/962/N/6
Updated with Decision(2012)8012 of 31/10/2012
19/09/2012 Centralised - Variation EMEA/H/C/962/IAin/8/G
Updated with Decision(2012)8012 of 31/10/2012
12/11/2012 Centralised - Variation (2012)8012 of 31/10/2012
29/08/2013 Centralised - Renewal EMEA/H/C/962/R/9 (2013)5605 of 26/08/2013
08/09/2014 Referral EMEA/H/C/962/A-31/1370 (2014)6386 of 04/09/2014