Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Telmisartan Teva   
Auth. number : EU/1/09/610
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: Hypertension
Treatment of essential hypertension in adults.
Cardiovascular prevention
Reduction of cardiovascular morbidity in patients with:
i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
ii) type 2 diabetes mellitus with documented target organ damage.
Marketing Authorisation Holder: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, 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
28/01/2010 Centralised - Authorisation EMEA/H/C/1146 (2010)566 of 26/01/2010
28/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1146/IB/2
12/04/2011 Centralised - Variation EMEA/H/C/1146/IA/1/G
Updated with Decision(2011)4845 of 29/06/2011
05/07/2011 Centralised - Variation (2011)4845 of 29/06/2011
09/09/2011 Centralised - Variation EMEA/H/C/1146/IB/4/G
Updated with Decision(2012)3210 of 10/05/2012
14/05/2012 Centralised - Variation (2012)3210 of 10/05/2012
21/05/2012 Centralised - Variation EMEA/H/C/1146/IA/6/G
Updated with Decision(2012)6132 of 30/08/2012
27/07/2012 Centralised - Variation EMEA/H/C/1146/IB/7/G
Updated with Decision(2012)7856 of 29/10/2012
03/09/2012 Centralised - Variation (2012)6132 of 30/08/2012
31/10/2012 Centralised - Variation (2012)7856 of 29/10/2012
10/10/2013 Centralised - Variation EMEA/H/C/1146/IB/12/G
Updated with Decision(2014)6379 of 04/09/2014
30/04/2014 Centralised - Variation EMEA/H/C/1146/IB/15
Updated with Decision(2014)6379 of 04/09/2014
08/09/2014 Referral EMEA/H/C/1146/A-31/1370 (2014)6379 of 04/09/2014