Bovalto Ibraxion

RSS
Withdrawn

This medicine's authorisation has been withdrawn

Infectious bovine rhinotracheitis vaccine (inactivated)
MedicineVeterinaryWithdrawn
  • Application under evaluation
  • CVMP opinion
  • European Commission decision

Overview

The marketing authorisation for Bovalto Ibraxion has been withdrawn at the request of the marketing authorisation holder.

Bovalto Ibraxion : EPAR - Summary for the public

English (EN) (211.7 KB - PDF)

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български (BG) (273.86 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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español (ES) (211.53 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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čeština (CS) (261.66 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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dansk (DA) (213.32 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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Deutsch (DE) (220.08 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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eesti keel (ET) (204.87 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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ελληνικά (EL) (286.33 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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français (FR) (212.65 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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hrvatski (HR) (231.45 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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italiano (IT) (209.38 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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latviešu valoda (LV) (244.51 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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lietuvių kalba (LT) (233 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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magyar (HU) (249.94 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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Malti (MT) (258.21 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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Nederlands (NL) (211.02 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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polski (PL) (256.51 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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português (PT) (211.11 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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română (RO) (235.21 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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slovenčina (SK) (258.12 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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slovenščina (SL) (244.33 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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Suomi (FI) (209.31 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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svenska (SV) (209.74 KB - PDF)

First published: 02/05/2007Last updated: 13/08/2019
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Product information

Bovalto Ibraxion : EPAR - Product Information

English (EN) (673.53 KB - PDF)

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български (BG) (705.71 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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español (ES) (674.36 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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čeština (CS) (969.79 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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dansk (DA) (624.29 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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Deutsch (DE) (661.81 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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eesti keel (ET) (692.55 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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ελληνικά (EL) (1.19 MB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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français (FR) (671.79 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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hrvatski (HR) (767.57 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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íslenska (IS) (680.52 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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italiano (IT) (679.81 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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latviešu valoda (LV) (999.57 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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lietuvių kalba (LT) (791.74 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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magyar (HU) (981.94 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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Malti (MT) (1007.77 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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Nederlands (NL) (671.31 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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norsk (NO) (684.14 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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polski (PL) (993.05 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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português (PT) (664.06 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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română (RO) (792.26 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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slovenčina (SK) (995.67 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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slovenščina (SL) (960.57 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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Suomi (FI) (678.92 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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svenska (SV) (676.34 KB - PDF)

First published: 04/04/2008Last updated: 13/08/2019
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Latest procedure affecting product information: IAIN/0016
10/08/2016

Bovalto Ibraxion : EPAR - All Authorised presentations

English (EN) (172.18 KB - PDF)

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български (BG) (333.69 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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español (ES) (172.7 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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čeština (CS) (205.62 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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dansk (DA) (172.68 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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Deutsch (DE) (173.21 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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eesti keel (ET) (168.31 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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ελληνικά (EL) (215.76 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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français (FR) (171.23 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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hrvatski (HR) (192.67 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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íslenska (IS) (170.24 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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italiano (IT) (168.65 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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latviešu valoda (LV) (209.34 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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lietuvių kalba (LT) (200.78 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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magyar (HU) (191.94 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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Malti (MT) (214.75 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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Nederlands (NL) (170.59 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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norsk (NO) (168.61 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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polski (PL) (207.14 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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português (PT) (172.47 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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română (RO) (195.44 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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slovenčina (SK) (209.19 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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slovenščina (SL) (240.02 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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Suomi (FI) (166.83 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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svenska (SV) (172.67 KB - PDF)

First published: 07/08/2006Last updated: 13/08/2019
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Product details

Name of medicine
Bovalto Ibraxion
Active substance
inactivated IBR virus
International non-proprietary name (INN) or common name
Infectious bovine rhinotracheitis vaccine (inactivated)
Species
Cattle
Anatomical therapeutic chemical veterinary (ATCvet) code
QI02AA03

Pharmacotherapeutic group

Immunologicals for Bovidae

Therapeutic indication

Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
The onset of immunity is 14 days and the duration of immunity is 6 months.

Authorisation details

EMA product number
EMEA/V/C/000051
Marketing authorisation holder
Merial

29 Avenue Tony Garnier
69007 Lyon
France

Marketing authorisation issued
09/03/2000
Revision
10

Assessment history

Bovalto Ibraxion : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (222.93 KB - PDF)

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Bovalto Ibraxion : EPAR - Procedural steps taken before authorisation

English (EN) (168.89 KB - PDF)

First published: Last updated:
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Bovalto Ibraxion : EPAR - Scientific Discussion

English (EN) (449.42 KB - PDF)

First published: Last updated:
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