BTVPUR Alsap 8

bluetongue virus serotype 8 antigen

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The marketing authorisation for BTVPUR AlSap 8 has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
BTVPUR Alsap 8 : EPAR - Summary for the public BG = bălgarski 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public ES = español 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public CS = čeština 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public DA = dansk 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public DE = Deutsch 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public ET = eesti keel 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public EL = elliniká 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public EN = English 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public FR = français 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public IT = italiano 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public LV = latviešu valoda 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public LT = lietuvių kalba 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public HU = magyar 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public MT = Malti 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public NL = Nederlands 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public PL = polski 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public PT = português 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public RO = română 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public SK = slovenčina 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public SL = slovenščina 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public FI = suomi 2013-04-19 2018-05-16
BTVPUR Alsap 8 : EPAR - Summary for the public SV = svenska 2013-04-19 2018-05-16

This EPAR was last updated on 16/05/2018 .

Authorisation details

Product details

Product details for BTVPUR Alsap 8
NameBTVPUR Alsap 8
Agency product numberEMEA/V/C/000146
Active substance

bluetongue virus serotype 8 antigen

International non-proprietary name (INN) or common name

adjuvanted bluetongue virus vaccine

Species SheepCattle
Anatomical therapeutic chemical veterinary (ATCvet) codes QI02AA08









Publication details

Publication details for BTVPUR Alsap 8
Marketing-authorisation holder

Merial

Revision5
Date of issue of marketing authorisation valid throughout the European Union17/03/2009

Contact address:

Merial
29, avenue Tony Garnier
69007 Lyon
France

Product information

Product information

12/03/2014  BTVPUR Alsap 8 -EMEA/V/C/000146 -R/0010

Name Language First published Last updated
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8 : EPAR - Product Information SV = svenska 2010-01-25 2018-05-16

Contents

  • 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.


Name Language First published Last updated
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16
BTVPUR Alsap 8 : EPAR - All Authorised presentations SV = svenska 2009-03-09 2018-05-16

Pharmacotherapeutic group

Immunologicals For ovidae; immunologicals for bovidae

Therapeutic indication

Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
*(below the level of detection by the validated RT-PCR method at 3.14log10 RNA copies/ml, indicating no infectious virus transmission).

Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.

The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.

The duration of immunity is not yet fully established in cattle or sheep, although interim results of ongoing studies demonstrate that the duration is at least 6 months after the primary vaccination course in sheep.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
BTVPUR Alsap 8 : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2010-01-25 2018-05-16
BTVPUR Alsap 8-V-C-146-S-08 : EPAR - Assessment Report - Variation SV = svenska 2012-10-10 2018-05-16

Initial marketing-authorisation documents