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Community Register of medicinal products

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Onduarp   
Auth. number : EU/1/11/729
INN : telmisartan / amlodipine
ATC: C - Cardiovascular system
C09 - Agents acting on the renin-angiotensin system
C09D - Angiotensin II antagonists, combinations
C09DB - Angiotensin II antagonists and calcium channel blockers
C09DB04 - Telmisartan and amlodipine
(See WHO ATC Index)
Indication: Treatment of essential hypertension in adults:

Add on therapy
ONDUARP is 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 of ONDUARP 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

The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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
28/11/2011 Centralised - Authorisation EMEA/H/C/2118 (2011)8853 of 24/11/2011
30/05/2012 Centralised - Variation EMEA/H/C/2118/WS/236 (2012)3569 of 25/05/2012
26/10/2012 Centralised - Variation EMEA/H/C/2118/WS/283 (2012)7677 of 24/10/2012
25/04/2013 Centralised - Variation EMEA/H/C/2118/WS/362