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
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: Treatment of essential hypertension in adults.
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 continues to be 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
09/10/2013 Centralised - Variation EMEA/H/C/2511/IB/8/G