Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Tolura   
Auth. number : EU/1/10/632
INN : 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
08/06/2010 Centralised - Authorisation EMEA/H/C/1196 (2010)3711 of 04/06/2010
06/10/2010 Centralised - Variation EMEA/H/C/1196/IB/1
Updated with Decision(2011)2954 of 20/04/2011
02/02/2011 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
06/11/2012 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
08/09/2014 Referral EMEA/H/C/1196/A-31/1370 (2014)6394 of 04/09/2014