Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Actelsar HCT   
Auth. number : EU/1/13/817
Active substance : telmisartan / hydrochlorothiazide
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C09 - Agents acting on the renin-angiotensin system
Pharmacological subgroup: C09D - Angiotensin II antagonists, combinations
Chemical subgroup: C09DA - Angiotensin II antagonists and diuretics
Chemical substance: C09DA07 - Telmisartan and diuretics
(See WHO ATC Index)
Indication: Treatment of essential hypertension. Actelsar HCT fixed dose combination (40 mg telmisartan/12.5 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on telmisartan alone
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
15/03/2013 Centralised - Authorisation EMEA/H/C/2676 (2013)1643 of 13/03/2013
09/08/2013 Centralised - Variation EMEA/H/C/2676/IB/4/G
Updated with Decision(2014)6363 of 04/09/2014
23/09/2013 Centralised - Variation EMEA/H/C/2676/IB/5/G
Updated with Decision(2014)6363 of 04/09/2014
30/09/2013 Centralised - Variation EMEA/H/C/2676/IB/6/G
Updated with Decision(2014)6363 of 04/09/2014
27/11/2013 Centralised - Notification EMEA/H/C/2676/N/7
Updated with Decision(2014)6363 of 04/09/2014
23/04/2014 Centralised - Variation EMEA/H/C/2676/IB/8
Updated with Decision(2014)6363 of 04/09/2014
08/09/2014 Referral EMEA/H/C/1370/A-31/2676/3 (2014)6363 of 04/09/2014
26/01/2015 Centralised - Notification EMEA/H/C/2676/N/10
11/12/2015 Centralised - Notification EMEA/H/C/2676/N/11
20/04/2016 Centralised - Notification EMEA/H/C/2676/N/13