Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Twynsta   
Auth. number : EU/1/10/648
Active substance : telmisartan / amlodipine
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: C09DB - Angiotensin II antagonists and calcium channel blockers
Chemical substance: C09DB04 - Telmisartan and amlodipine
(See WHO ATC Index)
Indication: Treatment of essential hypertension in adults:
Add on therapy
indicated in adults whose blood pressure is not adequately controlled on amlodipine.
Replacement therapy
Adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets containing the same component doses.
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland
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
11/10/2010 Centralised - Authorisation EMEA/H/C/1224 (2010)7080 of 07/10/2010
15/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1224/IA/1/G
16/06/2011 Centralised - Variation EMEA/H/C/1224/II/2, 3, 4 (2011)4289 of 14/06/2011
05/07/2011 Centralised - Variation EMEA/H/C/1224/IB/6
Updated with Decision(2012)1380 of 27/02/2012
29/02/2012 Centralised - Variation (2012)1380 of 27/02/2012
01/06/2012 Centralised - Variation EMEA/H/C/1224/WS/236 (2012)3617 of 25/05/2012
29/10/2012 Centralised - Variation EMEA/H/C/1224/WS/283 (2012)7722 of 25/10/2012
14/08/2013 PSUSA - Maintain EMEA/H/C/1224/PSU/7, EMEA/H/C/1224/WS/362 (2013)5448 of 12/08/2013
07/10/2013 Centralised - Notification EMEA/H/C/1224/N/18
Updated with Decision(2014)6377 of 04/09/2014
17/02/2014 Rectificative Decision (2014)1054 of 13/02/2014
08/09/2014 Referral EMEA/H/C/1224/A-31/1370 (2014)6377 of 04/09/2014
24/08/2015 Centralised - Renewal EMEA/H/C/1224/R/26 (2015)5970 of 20/08/2015
17/03/2016 Centralised - Variation EMEA/H/C/1224/II/28