Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Onduarp
Auth. number : EU/1/11/729
INN : 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
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

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
Updated with Decision(2013)4620 of 15/07/2013
17/07/2013 Centralised - Modification EMEA/H/C/2118/PSU/4 (2013)4620 of 15/07/2013
07/10/2013 Centralised - Variation EMEA/H/C/2118/N/12
17/02/2014 Rectificative Decision (2014)1056 of 13/02/2014
19/02/2014 Centralised - Withdrawal (2014)1133 of 17/02/2014