Overview

The marketing authorisation for Sprimeo has been withdrawn at the request of the marketing-authorisation holder.

 

Sprimeo : EPAR - Summary for the public

English (EN) (274.9 KB - PDF)

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български (BG) (342.15 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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español (ES) (259.26 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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čeština (CS) (311.96 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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dansk (DA) (258.54 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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Deutsch (DE) (260.03 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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eesti keel (ET) (258.16 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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ελληνικά (EL) (347.65 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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français (FR) (319.2 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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italiano (IT) (259.5 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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latviešu valoda (LV) (316.27 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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lietuvių kalba (LT) (282.88 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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magyar (HU) (307.75 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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Malti (MT) (311.55 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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Nederlands (NL) (259.07 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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polski (PL) (372.79 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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português (PT) (335.06 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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română (RO) (282.51 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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slovenčina (SK) (310.95 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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slovenščina (SL) (308.01 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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Suomi (FI) (318.25 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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svenska (SV) (319.06 KB - PDF)

First published: 08/05/2009Last updated: 20/08/2012
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Product information

Sprimeo : EPAR - Product Information

English (EN) (1.01 MB - PDF)

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български (BG) (2.32 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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español (ES) (1.03 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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čeština (CS) (1.65 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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dansk (DA) (1.09 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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Deutsch (DE) (1.14 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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eesti keel (ET) (1.09 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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ελληνικά (EL) (2.29 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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français (FR) (1.15 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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íslenska (IS) (1.1 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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italiano (IT) (1.14 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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latviešu valoda (LV) (1.74 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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lietuvių kalba (LT) (1.06 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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magyar (HU) (1.7 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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Malti (MT) (1.81 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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Nederlands (NL) (1.08 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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norsk (NO) (1.11 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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polski (PL) (1.73 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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português (PT) (1.02 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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română (RO) (1.07 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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slovenčina (SK) (1.79 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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slovenščina (SL) (1.68 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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Suomi (FI) (1.03 MB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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svenska (SV) (1019.89 KB - PDF)

First published: 18/06/2009Last updated: 20/08/2012
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Latest procedure affecting product information: II/0039

04/07/2012

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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).

Sprimeo : EPAR - All Authorised presentations

English (EN) (345 KB - PDF)

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български (BG) (427.3 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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español (ES) (369.76 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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čeština (CS) (387.75 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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dansk (DA) (344.96 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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Deutsch (DE) (351.03 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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eesti keel (ET) (348.09 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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ελληνικά (EL) (430.1 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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français (FR) (373.1 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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íslenska (IS) (367.27 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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italiano (IT) (367.54 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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latviešu valoda (LV) (369.95 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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lietuvių kalba (LT) (374.13 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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magyar (HU) (385.82 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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Malti (MT) (389.44 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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Nederlands (NL) (365.63 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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norsk (NO) (369.99 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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polski (PL) (399.45 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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português (PT) (369.22 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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română (RO) (369.48 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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slovenčina (SK) (390.13 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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slovenščina (SL) (399.01 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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Suomi (FI) (344.56 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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svenska (SV) (370.53 KB - PDF)

First published: 03/09/2007Last updated: 20/08/2012
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Product details

Name of medicine
Sprimeo
Active substance
aliskiren
International non-proprietary name (INN) or common name
aliskiren
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09XA02

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Authorisation details

EMA product number
EMEA/H/C/000851
Marketing authorisation holder
Novartis Europharm Ltd.

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Marketing authorisation issued
22/08/2007
Revision
5

Assessment history

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

English (EN) (528.14 KB - PDF)

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Sprimeo-H-C-xxxx-WS-0069 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/74385/2012

English (EN) (293.47 KB - PDF)

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Sprimeo-H-C-851-A-20-0067 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/391075/2012

English (EN) (655.03 KB - PDF)

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Sprimeo-H-C-xxxx-WS-0169 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/479606/2012

English (EN) (384.18 KB - PDF)

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Sprimeo-H-C-xxxx-WS-0037 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/479605/2012

English (EN) (3.03 MB - PDF)

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Sprimeo : EPAR - Scientific Discussion

English (EN) (679.84 KB - PDF)

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Sprimeo : EPAR - Procedural steps taken before authorisation

English (EN) (224.02 KB - PDF)

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More information on Sprimeo

Questions and answers on the review aliskiren-containing medicines

Reference Number: EMA/113677/2012

English (EN) (60.98 KB - PDF)

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Questions and answers on ongoing review of aliskiren-containing medicines

Reference Number: EMA/990270/2011

English (EN) (65.3 KB - PDF)

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

Reference Number: EMA/328034/2012

English (EN) (43.05 KB - PDF)

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