Spironolactone Ceva

RSS
Withdrawn

This medicine's authorisation has been withdrawn

spironolactone
MedicineVeterinaryWithdrawn
  • Application under evaluation
  • CVMP opinion
  • European Commission decision

Overview

The marketing authorisation for this product has been withdrawn due to the application of the sunset clause.

Prilactone : EPAR - Medicine overview

English (EN) (312.06 KB - PDF)

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български (BG) (332.91 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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español (ES) (288.28 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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čeština (CS) (322.23 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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dansk (DA) (287.53 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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Deutsch (DE) (289.53 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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eesti keel (ET) (276.29 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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ελληνικά (EL) (335.21 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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français (FR) (289.25 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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hrvatski (HR) (307.68 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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latviešu valoda (LV) (334.28 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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Malti (MT) (324.47 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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Nederlands (NL) (287.82 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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polski (PL) (380.69 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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português (PT) (288.12 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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română (RO) (482.45 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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slovenčina (SK) (324.97 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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slovenščina (SL) (318.42 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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Suomi (FI) (285.73 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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svenska (SV) (287.15 KB - PDF)

First published: 18/07/2007 Last updated: 24/02/2021
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Product information

Spironolactone Ceva : EPAR - Product Information

English (EN) (442.36 KB - PDF)

First published: Last updated:
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български (BG) (936.84 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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español (ES) (457.64 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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čeština (CS) (695.23 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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dansk (DA) (443.55 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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Deutsch (DE) (456.17 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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eesti keel (ET) (460.88 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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ελληνικά (EL) (957.24 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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français (FR) (383.63 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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hrvatski (HR) (504.46 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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íslenska (IS) (622.5 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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italiano (IT) (614.01 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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latviešu valoda (LV) (750.12 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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lietuvių kalba (LT) (673.01 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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magyar (HU) (1.07 MB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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Malti (MT) (774.79 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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Nederlands (NL) (445.92 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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norsk (NO) (656.3 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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polski (PL) (1.09 MB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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português (PT) (456.69 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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română (RO) (807.04 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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slovenčina (SK) (711.68 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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slovenščina (SL) (702.28 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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Suomi (FI) (456.54 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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svenska (SV) (441.7 KB - PDF)

First published: 30/07/2009 Last updated: 27/11/2017
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Latest procedure affecting product information:IAIN/0014
31/10/2012

Spironolactone Ceva : EPAR - All Authorised presentations

English (EN) (395.25 KB - PDF)

First published: Last updated:
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български (BG) (299.51 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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español (ES) (219.22 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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čeština (CS) (262.67 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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dansk (DA) (227.42 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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Deutsch (DE) (218.75 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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eesti keel (ET) (221.16 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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ελληνικά (EL) (268.37 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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français (FR) (221.14 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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hrvatski (HR) (227.55 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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íslenska (IS) (185.95 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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italiano (IT) (191.92 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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latviešu valoda (LV) (256.74 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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lietuvių kalba (LT) (210.34 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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magyar (HU) (210.45 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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Malti (MT) (250.85 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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Nederlands (NL) (228.06 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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norsk (NO) (222.67 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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polski (PL) (245.92 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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português (PT) (231.37 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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română (RO) (434.62 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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slovenčina (SK) (253.67 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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slovenščina (SL) (237.31 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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Suomi (FI) (204.11 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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svenska (SV) (218.51 KB - PDF)

First published: 18/07/2007 Last updated: 30/11/2016
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Product details

Name of medicine
Spironolactone Ceva
Active substance
spironolactone
International non-proprietary name (INN) or common name
spironolactone
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) code
QC03DA01

Pharmacotherapeutic group

Diuretics

Therapeutic indication

For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.

Authorisation details

EMA product number
EMEA/V/C/000105
Marketing authorisation holder
Ceva Santé Animale

10 avenue de la Ballastière
33500 Libourne
France

Opinion adopted
17/04/2007
Marketing authorisation issued
20/06/2007
Revision
7

Assessment history

Spironolactone Ceva : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (254.31 KB - PDF)

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Prilactone : EPAR - Procedural steps taken before authorisation

English (EN) (169.98 KB - PDF)

First published: Last updated:
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Prilactone : EPAR - Scientific Discussion

English (EN) (336.55 KB - PDF)

First published: Last updated:
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