Onduarp

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Withdrawn

This medicine's authorisation has been withdrawn

telmisartan / amlodipine
MedicineHumanWithdrawn
  • 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decision, the European public assessment report for Onduarp is updated to reflect that the marketing authorisation is no longer valid.

Onduarp : EPAR - Summary for the public

Reference Number: EMA/810673/2011

English (EN) (522.95 KB - PDF)

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български (BG) (630.81 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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español (ES) (540.23 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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čeština (CS) (592.53 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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dansk (DA) (576.08 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Deutsch (DE) (544.29 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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eesti keel (ET) (523.65 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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ελληνικά (EL) (636.8 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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français (FR) (525.51 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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italiano (IT) (525.8 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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latviešu valoda (LV) (599.49 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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lietuvių kalba (LT) (554.08 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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magyar (HU) (583.99 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Malti (MT) (593.57 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Nederlands (NL) (523.66 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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polski (PL) (594.97 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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português (PT) (523.91 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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română (RO) (554.71 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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slovenčina (SK) (589.48 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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slovenščina (SL) (586.59 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Suomi (FI) (524.68 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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svenska (SV) (583.76 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Product information

Onduarp : EPAR - Product Information

English (EN) (1.42 MB - PDF)

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български (BG) (4.78 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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español (ES) (1.58 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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čeština (CS) (3.16 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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dansk (DA) (1.55 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Deutsch (DE) (1.49 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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eesti keel (ET) (1.39 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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ελληνικά (EL) (5.04 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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français (FR) (1.5 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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hrvatski (HR) (1.1 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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íslenska (IS) (561.49 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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italiano (IT) (1.46 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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latviešu valoda (LV) (3.58 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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lietuvių kalba (LT) (1.81 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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magyar (HU) (3.15 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Malti (MT) (3.35 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Nederlands (NL) (1.47 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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norsk (NO) (580.92 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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polski (PL) (3.44 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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português (PT) (1.47 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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română (RO) (1.87 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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slovenčina (SK) (3.3 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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slovenščina (SL) (3.26 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Suomi (FI) (1.53 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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svenska (SV) (1.43 MB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Latest procedure affecting product information: WS/0236
17/02/2014
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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).

Onduarp : EPAR - All Authorised presentations

English (EN) (476.3 KB - PDF)

First published: Last updated:
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български (BG) (530.2 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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español (ES) (476.78 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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čeština (CS) (511.93 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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dansk (DA) (487.48 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Deutsch (DE) (476.11 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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eesti keel (ET) (476.63 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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ελληνικά (EL) (536.96 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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français (FR) (487.46 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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íslenska (IS) (25.81 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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italiano (IT) (474.03 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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latviešu valoda (LV) (518.12 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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lietuvių kalba (LT) (517.38 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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magyar (HU) (528.6 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Malti (MT) (527.28 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Nederlands (NL) (475.98 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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norsk (NO) (19.76 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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polski (PL) (507.57 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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português (PT) (487.82 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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română (RO) (515 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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slovenčina (SK) (512.76 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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slovenščina (SL) (499.61 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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Suomi (FI) (487.61 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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svenska (SV) (476.49 KB - PDF)

First published: 08/12/2011Last updated: 02/04/2014
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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 system

Therapeutic 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.

Authorisation details

EMA product number
EMEA/H/C/002118
Marketing authorisation holder
Boehringer Ingelheim International GmbH

Binger Strasse 173
D-55216 Ingelheim am Rhein
Germany

Marketing authorisation issued
24/11/2011
Withdrawal of marketing authorisation
17/02/2014
Revision
2

Assessment history

Onduarp : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (576.31 KB - PDF)

First published: Last updated:
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CHMP post-authorisation summary of positive opinion for Onduarp

Reference Number: EMA/CHMP/261191/2013

English (EN) (528.91 KB - PDF)

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Onduarp : EPAR - Public assessment report

AdoptedReference Number: EMA/891763/2011

English (EN) (613.86 KB - PDF)

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CHMP summary of positive opinion for Onduarp

AdoptedReference Number: EMA/CHMP/690726/2011

English (EN) (509.84 KB - PDF)

First published: Last updated:
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