Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Telmisartan Teva Pharma   
Auth. number : EU/1/11/719
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: Hypertension
Treatment of essential hypertension in adults.

Cardiovascular prevention
Reduction of cardiovascular morbidity in adults with:
• manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
• type 2 diabeted mellitus with documented target organ damage
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, 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
05/10/2011 Centralised - Authorisation EMEA/H/C/2511 (2011)7179 of 03/10/2011
21/05/2012 Centralised - Variation EMEA/H/C/2511/IA/2/G
Updated with Decision(2012)7857 of 29/10/2012
27/07/2012 Centralised - Variation EMEA/H/C/2511/IB/3/G
Updated with Decision(2012)7857 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7857 of 29/10/2012
05/06/2013 Centralised - Variation EMEA/H/C/2511/IAin/5/G
Updated with Decision(2014)3948 of 06/06/2014
09/10/2013 Centralised - Variation EMEA/H/C/2511/IB/8/G
Updated with Decision(2014)3948 of 06/06/2014
30/04/2014 Centralised - Variation EMEA/H/C/2511/IB/11
Updated with Decision(2014)3948 of 06/06/2014
12/06/2014 Centralised - Yearly update (2014)3948 of 06/06/2014
08/09/2014 Referral EMEA/H/C/2511/A-31/1370 (2014)6380 of 04/09/2014
12/02/2015 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2511/T/12 (2015)808 of 10/02/2015
19/04/2016 Centralised - Variation EMEA/H/C/2511/IA/15/G
Updated with Decision(2016)3706 of 09/06/2016
13/06/2016 Centralised - Renewal EMEA/H/C/2511/R/14 (2016)3706 of 09/06/2016