BTVPUR AlSap 1

bluetongue-virus serotype-1 antigen

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The marketing authorisation for BTVPUR AlSap 1 has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
BTVPUR AlSap 1 : EPAR - Summary for the public BG = bălgarski 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public ES = español 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public CS = čeština 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public DA = dansk 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public DE = Deutsch 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public ET = eesti keel 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public EL = elliniká 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public EN = English 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public FR = français 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public IT = italiano 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public LV = latviešu valoda 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public LT = lietuvių kalba 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public HU = magyar 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public MT = Malti 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public NL = Nederlands 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public PL = polski 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public PT = português 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public RO = română 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public SK = slovenčina 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public SL = slovenščina 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public FI = suomi 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Summary for the public SV = svenska 2011-01-03 2018-05-17

This EPAR was last updated on 17/05/2018 .

Authorisation details

Product details

Product details for BTVPUR AlSap 1
NameBTVPUR AlSap 1
Agency product numberEMEA/V/C/002230
Active substance

bluetongue-virus serotype-1 antigen

International non-proprietary name (INN) or common name

bluetongue-virus serotype-1 antigen

Species SheepCattle
Anatomical therapeutic chemical veterinary (ATCvet) codes QI04AA02



Publication details

Publication details for BTVPUR AlSap 1
Marketing-authorisation holder

Merial

Revision4
Date of issue of marketing authorisation valid throughout the European Union17/12/2010

Contact address:

Merial
29 avenue Tony Garnier
69007 Lyon
France

Product information

Product information

08/09/2015  BTVPUR AlSap 1 -EMEA/V/C/002230 -R/0005

Name Language First published Last updated
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - Product Information SV = svenska 2011-01-03 2018-05-17

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 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17
BTVPUR AlSap 1 : EPAR - All Authorised presentations SV = svenska 2011-01-03 2018-05-17

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotype 1.

Onset of immunity has been demonstrated three weeks after the primary vaccination course. The duration of immunity for cattle and sheep is one year after the primary vaccination course.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
BTVPUR AlSap 1 : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2012-05-04 2018-05-17
BTVPUR AlSap 1-V-C-2230-S-02 : EPAR - Assessment Report - Annual re-assessment SV = svenska 2013-05-13 2018-05-17

Initial marketing-authorisation documents

Name Language First published Last updated
BTVPUR AlSap 1 : EPAR - Scientific Discussion SV = svenska 2011-01-03 2018-05-17
CVMP summary of positive opinion for BTVPUR AlSap 1 SV = svenska 2010-10-15 2018-05-17