Sileo

Page contents

Overview
Product information
Product details
Authorisation details
Assessment history
News on Sileo

Application under evaluation
CVMP opinion
European Commission decision

Overview

Up-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website

Sileo : EPAR - Summary for the public

English (EN) (81.94 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Other languages (25)

български (BG) (93.36 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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español (ES) (81.97 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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čeština (CS) (93.99 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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dansk (DA) (83.34 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Deutsch (DE) (82.76 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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eesti keel (ET) (82.18 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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ελληνικά (EL) (93.76 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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français (FR) (82.44 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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hrvatski (HR) (92.27 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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íslenska (IS) (83.29 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Gaeilge (GA) (83.57 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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italiano (IT) (82.29 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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latviešu valoda (LV) (94.29 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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lietuvių kalba (LT) (94.03 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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magyar (HU) (94.15 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Malti (MT) (95.95 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Nederlands (NL) (82.05 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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norsk (NO) (82 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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polski (PL) (95.62 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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português (PT) (83.01 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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română (RO) (94.17 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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slovenčina (SK) (94.08 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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slovenščina (SL) (82.27 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Suomi (FI) (81.54 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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svenska (SV) (82.05 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Product information

Sileo : EPAR - Product Information

English (EN) (81.49 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Other languages (25)

български (BG) (91.78 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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español (ES) (81.51 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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čeština (CS) (92.48 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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dansk (DA) (82.05 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Deutsch (DE) (81.72 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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eesti keel (ET) (81.22 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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ελληνικά (EL) (91.79 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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français (FR) (81.63 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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hrvatski (HR) (91.56 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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íslenska (IS) (81.52 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Gaeilge (GA) (81.36 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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italiano (IT) (81.76 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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latviešu valoda (LV) (92.14 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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lietuvių kalba (LT) (92.19 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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magyar (HU) (92.76 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Malti (MT) (93.86 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Nederlands (NL) (81.15 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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norsk (NO) (81.52 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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polski (PL) (93.22 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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português (PT) (82.53 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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română (RO) (91.73 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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slovenčina (SK) (81.75 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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slovenščina (SL) (81.76 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Suomi (FI) (81.11 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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svenska (SV) (81.47 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Sileo : EPAR - All Authorised presentations

English (EN) (81.94 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Other languages (25)

български (BG) (93.36 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

español (ES) (81.97 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

čeština (CS) (93.99 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

dansk (DA) (83.34 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

Deutsch (DE) (82.76 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

eesti keel (ET) (82.18 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

ελληνικά (EL) (93.76 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

français (FR) (82.44 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

hrvatski (HR) (92.27 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

íslenska (IS) (83.29 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

Gaeilge (GA) (83.57 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

italiano (IT) (82.29 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

latviešu valoda (LV) (94.29 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

lietuvių kalba (LT) (94.03 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

magyar (HU) (94.15 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

Malti (MT) (95.95 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

Nederlands (NL) (82.05 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

norsk (NO) (82 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

polski (PL) (95.62 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

português (PT) (83.01 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

română (RO) (94.17 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

slovenčina (SK) (94.08 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

slovenščina (SL) (82.27 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

View

Suomi (FI) (81.54 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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svenska (SV) (82.05 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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Product details

Name of medicine: Sileo
Active substance: Dexmedetomidine hydrochloride
International non-proprietary name (INN) or common name: dexmedetomidine

Pharmacotherapeutic group

Nervous system
Other hypnotics and sedatives

Authorisation details

EMA product number: EMEA/V/C/003764

Assessment history

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

English (EN) (81.94 KB - PDF)

First published: 10/02/2016Last updated: 21/06/2024

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Sileo : EPAR - Public assessment report

Adopted

English (EN) (81.49 KB - PDF)

First published: 07/07/2015Last updated: 21/06/2024

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CVMP summary of positive opinion for Sileo

AdoptedReference Number: EMA/CVMP/123810/2015

English (EN) (74.9 KB - PDF)

First published: 13/04/2015Last updated: 13/04/2015

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News on Sileo

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 May 2022

13/05/2022

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 18-20 February 2020

21/02/2020

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-22 May 2019

24/05/2019

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 5–7 December 2017

08/12/2017

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 10-12 May 2017

15/05/2017

Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 November 2016

11/11/2016

Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 19-21 April 2016

22/04/2016

Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 8-10 April 2015

13/04/2015

This page was last updated on 21/06/2024

Authorised

Overview

Product information

Product details

Pharmacotherapeutic group

Authorisation details

Assessment history

Changes since initial authorisation of medicine

Initial marketing authorisation documents

News on Sileo

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