Imprida

amlodipine / valsartan

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Imprida has been withdrawn at the request of the marketing authorisation holder.

List item

Imprida : EPAR - Summary for the public (PDF/541.81 KB)

First published: 05/05/2009
Last updated: 11/05/2017
- Bulgarian
  (PDF/633.91 KB)
- Croatian
  (PDF/565.16 KB)
- Czech
  (PDF/610.61 KB)
- Danish
  (PDF/543.07 KB)
- Dutch
  (PDF/542.41 KB)
- Estonian
  (PDF/540.73 KB)
- Finnish
  (PDF/542.15 KB)
- French
  (PDF/545.46 KB)
- German
  (PDF/545.51 KB)
- Greek
  (PDF/630.27 KB)
- Hungarian
  (PDF/602.95 KB)
- Italian
  (PDF/543.05 KB)
- Latvian
  (PDF/608.63 KB)
- Lithuanian
  (PDF/568.19 KB)
- Maltese
  (PDF/611.76 KB)
- Polish
  (PDF/609.65 KB)
- Portuguese
  (PDF/543.89 KB)
- Romanian
  (PDF/569.23 KB)
- Slovak
  (PDF/608.48 KB)
- Slovenian
  (PDF/596.71 KB)
- Spanish
  (PDF/566.39 KB)
- Swedish
  (PDF/543.48 KB)

More detail is available in the summary of product characteristics

This EPAR was last updated on 11/05/2017

Authorisation details

Product details
Name	Imprida
Agency product number	EMEA/H/C/000775
Active substance	amlodipine (as besylate) valsartan
International non-proprietary name (INN) or common name	amlodipine / valsartan
Therapeutic area (MeSH)	Hypertension
Anatomical therapeutic chemical (ATC) code	C09DB01

Publication details
Marketing-authorisation holder	Novartis Europharm Ltd
Revision	20
Date of issue of marketing authorisation valid throughout the European Union	17/01/2007
Contact address	Frimley Business Park Camberley GU16 7SR United Kingdom

Product information

03/04/2017 Imprida - EMEA/H/C/000775 - WS/0709

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Imprida : EPAR - Product Information (PDF/1.28 MB)

First published: 05/05/2009
Last updated: 11/05/2017
- Bulgarian
  (PDF/1.75 MB)
- Croatian
  (PDF/1.41 MB)
- Czech
  (PDF/3.34 MB)
- Danish
  (PDF/1.36 MB)
- Dutch
  (PDF/1.34 MB)
- Estonian
  (PDF/1.26 MB)
- Finnish
  (PDF/1.54 MB)
- French
  (PDF/1.76 MB)
- German
  (PDF/1.32 MB)
- Greek
  (PDF/1.69 MB)
- Hungarian
  (PDF/1.65 MB)
- Icelandic
  (PDF/1.92 MB)
- Italian
  (PDF/1.31 MB)
- Latvian
  (PDF/1.66 MB)
- Lithuanian
  (PDF/1.44 MB)
- Maltese
  (PDF/1.59 MB)
- Norwegian
  (PDF/1.31 MB)
- Polish
  (PDF/1.68 MB)
- Portuguese
  (PDF/1.9 MB)
- Romanian
  (PDF/1.43 MB)
- Slovak
  (PDF/1.59 MB)
- Slovenian
  (PDF/1.51 MB)
- Spanish
  (PDF/1.38 MB)
- Swedish
  (PDF/1.3 MB)

Annex I - Summary of product characteristics
Annex IIA - Manufacturing-authorisation holder responsible for batch release
Annex IIB - Conditions of the marketing authorisation
Annex IIIA - Labelling
Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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Imprida : EPAR - All Authorised presentations (PDF/599.25 KB)

First published: 20/05/2008
Last updated: 11/05/2017
- Bulgarian
  (PDF/736.89 KB)
- Czech
  (PDF/669.79 KB)
- Danish
  (PDF/599.89 KB)
- Dutch
  (PDF/600.11 KB)
- Estonian
  (PDF/608.27 KB)
- Finnish
  (PDF/605.01 KB)
- French
  (PDF/601.94 KB)
- German
  (PDF/600.18 KB)
- Greek
  (PDF/735.82 KB)
- Hungarian
  (PDF/719.36 KB)
- Italian
  (PDF/604.25 KB)
- Latvian
  (PDF/713.8 KB)
- Lithuanian
  (PDF/689.38 KB)
- Maltese
  (PDF/712.01 KB)
- Polish
  (PDF/665.55 KB)
- Portuguese
  (PDF/599.84 KB)
- Romanian
  (PDF/682.92 KB)
- Slovak
  (PDF/664.18 KB)
- Slovenian
  (PDF/625.43 KB)
- Spanish
  (PDF/600.94 KB)
- Swedish
  (PDF/143.2 KB)

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Imprida is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Assessment history

Changes since initial authorisation of medicine

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Imprida : EPAR - Procedural steps taken and scientific information after authorisation (PDF/897.08 KB)

First published: 05/05/2009
Last updated: 11/05/2017
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Imprida-H-C-775-A31-0069 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommenda... (PDF/527.93 KB)

First published: 30/09/2014
Last updated: 11/05/2017
- Bulgarian
  (PDF/683.53 KB)
- Croatian
  (PDF/567.49 KB)
- Czech
  (PDF/630.74 KB)
- Danish
  (PDF/528.78 KB)
- Dutch
  (PDF/531.92 KB)
- Estonian
  (PDF/530.67 KB)
- Finnish
  (PDF/529 KB)
- French
  (PDF/535.83 KB)
- German
  (PDF/539.46 KB)
- Greek
  (PDF/692.49 KB)
- Hungarian
  (PDF/613.31 KB)
- Italian
  (PDF/532.35 KB)
- Latvian
  (PDF/631.93 KB)
- Lithuanian
  (PDF/568.45 KB)
- Maltese
  (PDF/634.18 KB)
- Polish
  (PDF/629.43 KB)
- Portuguese
  (PDF/530.2 KB)
- Romanian
  (PDF/581.27 KB)
- Slovak
  (PDF/629.27 KB)
- Slovenian
  (PDF/79.79 KB)
- Spanish
  (PDF/532.05 KB)
- Swedish
  (PDF/50.18 KB)
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Imprida-H-C-775-A31-0069 : EPAR - Assessment Report - Article 31 (PDF/977.44 KB)

Adopted

First published: 30/09/2014
Last updated: 11/05/2017
EMA/PRAC/294920/2014
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Imprida-H-C-775-WS-0360 : EPAR - Assessment Report - Variation (PDF/899.8 KB)

Adopted

First published: 11/12/2013
Last updated: 11/05/2017
EMA/CHMP/356249/2013
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CHMP post-authorisation summary of positive opinion for Imprida (PDF/529.1 KB)

Adopted

First published: 28/06/2013
Last updated: 11/05/2017
EMA/CHMP/397194/2013
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Imprida-H-C-775-WS-0100-G : EPAR - Assessment Report - Variation (PDF/1.34 MB)

Adopted

First published: 07/09/2011
Last updated: 11/05/2017

Imprida

Table of contents

Overview

Imprida : EPAR - Summary for the public (PDF/541.81 KB)

Authorisation details

Product information

Imprida : EPAR - Product Information (PDF/1.28 MB)

Contents

Imprida : EPAR - All Authorised presentations (PDF/599.25 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Imprida : EPAR - Procedural steps taken and scientific information after authorisation (PDF/897.08 KB)

Imprida-H-C-775-A31-0069 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommenda... (PDF/527.93 KB)

Imprida-H-C-775-A31-0069 : EPAR - Assessment Report - Article 31 (PDF/977.44 KB)

Imprida-H-C-775-WS-0360 : EPAR - Assessment Report - Variation (PDF/899.8 KB)

CHMP post-authorisation summary of positive opinion for Imprida (PDF/529.1 KB)

Imprida-H-C-775-WS-0100-G : EPAR - Assessment Report - Variation (PDF/1.34 MB)

Initial marketing-authorisation documents

Imprida : EPAR - Procedural steps taken before authorisation (PDF/475.09 KB)

Imprida : EPAR - Scientific Discussion (PDF/949.06 KB)

News

More information on Imprida

Public statement on Imprida: Withdrawal of the marketing authorisation in the European Union (PDF/65.29 KB)

Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer (PDF/511.41 KB)

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