Overview

The marketing authorisation for Onduarp has been withdrawn at the request of the marketing-authorisation holder.

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)

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čeština (CS) (592.53 KB - PDF)

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dansk (DA) (576.08 KB - PDF)

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Deutsch (DE) (544.29 KB - PDF)

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eesti keel (ET) (523.65 KB - PDF)

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ελληνικά (EL) (636.8 KB - PDF)

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français (FR) (525.51 KB - PDF)

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italiano (IT) (525.8 KB - PDF)

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latviešu valoda (LV) (599.49 KB - PDF)

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lietuvių kalba (LT) (554.08 KB - PDF)

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magyar (HU) (583.99 KB - PDF)

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Malti (MT) (593.57 KB - PDF)

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Nederlands (NL) (523.66 KB - PDF)

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polski (PL) (594.97 KB - PDF)

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português (PT) (523.91 KB - PDF)

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română (RO) (554.71 KB - PDF)

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slovenčina (SK) (589.48 KB - PDF)

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slovenščina (SL) (586.59 KB - PDF)

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Suomi (FI) (524.68 KB - PDF)

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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)

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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
Revision
2

Assessment history

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

English (EN) (576.31 KB - PDF)

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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)

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More information on Onduarp

Public statement on Onduarp: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/133999/2014

English (EN) (79.29 KB - PDF)

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