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Community register of medicinal products for human use


Product information

Invented name: Telmisartan Actavis   
Auth. number : EU/1/10/639
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: Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland
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
5/10/2010 Centralised - Authorisation EMEA/H/C/1168 (2010)6912 of 30/09/2010
17/10/2011 Centralised - Variation EMEA/H/C/1168/IB/2/G
Updated with Decision(2012)3213 of 10/05/2012
14/05/2012 Centralised - Variation (2012)3213 of 10/05/2012
27/07/2012 Centralised - Variation EMEA/H/C/1168/IB/6
Updated with Decision(2012)7858 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7858 of 29/10/2012
30/07/2013 Centralised - Variation EMEA/H/C/1168/IB/8
Updated with Decision(2014)6381 of 04/09/2014
21/11/2013 Centralised - Variation EMEA/H/C/1168/IB/10/G
Updated with Decision(2014)6381 of 04/09/2014
23/04/2014 Centralised - Variation EMEA/H/C/1168/IB/11
Updated with Decision(2014)6381 of 04/09/2014
8/09/2014 Referral EMEA/H/C/1168/A-31/1370 (2014)6381 of 4/09/2014
23/06/2015 Centralised - Renewal EMEA/H/C/1168/R/14 (2015)4304 of 19/06/2015
5/07/2016 Centralised - Notification EMEA/H/C/1168/N/15
19/09/2017 Corrigendum (2014)6381 of 4/09/2014
20/03/2018 Centralised - Notification EMEA/H/C/1168/N/17