Onduarp
Withdrawn
This medicine's authorisation has been withdrawn
telmisartan / amlodipine
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 24 November 2011, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Onduarp, which combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine.
The marketing authorisation holder (MAH) responsible for Onduarp was Boehringer Ingelheim International GmbH. On 17 February 2014, the European Commission issued a decision to withdraw the marketing authorisation for Onduarp, following its receipt of a letter dated 20 December 2013 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons. Onduarp was not marketed in any European country.
Pursuant to this decision, the European public assessment report for Onduarp is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:WS/0236
17/02/2014
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Onduarp
- Active substance
- telmisartan
- International non-proprietary name (INN) or common name
- telmisartan
- amlodipine
- Therapeutic area (MeSH)
- Hypertension
- Anatomical therapeutic chemical (ATC) code
- C09DB04
Pharmacotherapeutic group
Cardiovascular systemTherapeutic 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.
News on Onduarp
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