Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Tolura   
Auth. number : EU/1/10/632
Active substance : telmisartan
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: C09CA07 - telmisartan
(See WHO ATC Index)
Indication: HypertensionTreatment of essential hypertension in adults.Cardiovascular preventionReduction of cardiovascular morbidity in patients with:i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) orii) type 2 diabetes mellitus with documented target organ damage
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
8/06/2010 Centralised - Authorisation EMEA/H/C/1196 (2010)3711 of 4/06/2010
6/10/2010 Centralised - Variation EMEA/H/C/1196/IB/1
Updated with Decision(2011)2954 of 20/04/2011
2/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1196/IB/2
28/04/2011 Centralised - Variation (2011)2954 of 20/04/2011
10/08/2011 Centralised - Variation EMEA/H/C/1196/IB/4/G
Updated with Decision(2012)8000 of 31/10/2012
27/07/2012 Centralised - Variation EMEA/H/C/1196/IB/8
Updated with Decision(2012)8000 of 31/10/2012
6/11/2012 Centralised - Variation (2012)8000 of 31/10/2012
19/07/2013 Centralised - Notification EMEA/H/C/1196/N/12
Updated with Decision(2014)6394 of 04/09/2014
24/09/2013 Centralised - Variation EMEA/H/C/1196/IB/14/G
Updated with Decision(2014)6394 of 04/09/2014
13/12/2013 Centralised - Variation EMEA/H/C/1196/IB/18/G
Updated with Decision(2014)6394 of 04/09/2014
22/05/2014 Centralised - Variation EMEA/H/C/1196/IB/19/G
Updated with Decision(2014)6394 of 04/09/2014
8/09/2014 Referral EMEA/H/C/1196/A-31/1370 (2014)6394 of 4/09/2014
23/03/2015 Centralised - Renewal EMEA/H/C/1196/R/22 (2015)2004 of 19/03/2015
29/06/2015 Centralised - Variation EMEA/H/C/1196/IB/24
Updated with Decision(2016)4072 of 24/06/2016
28/06/2016 Centralised - Yearly update (2016)4072 of 24/06/2016
24/01/2018 Corrigendum (2014)6394 of 4/09/2014
19/02/2018 Centralised - Notification EMEA/H/C/1196/N/28