Veterinary Medicines

Salmovac 440 Lyophilisate for use in drinking water

Authorised
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain 441/014, Live
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Product identification

Medicine name:
Salmovac 440 Lyophilisate for use in drinking water
CEVAC SALMOVAC LYOPHILISAT POUR ADMINISTRATION DANS L'EAU DE BOISSON
Active substance:
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain 441/014, Live
Target species:
  • Chicken
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain 441/014, Live
    800000000.00
    Colony forming unit
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • Egg
        3
        week
      • Meat and offal
        6
        week
      • Egg
        6
        week
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AE01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription except for some pack sizes
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • (ID4): 1 Box with 1 Vial (Glass) with 1000 vaccine doses (1000 vaccine doses)
  • (ID3): 1 Box with 12 Vials (Glass) with 5000 vaccine doses (60000 vaccine doses)
  • (ID2): 1 Box with 1 Vial (Glass) with 5000 vaccine doses (5000 vaccine doses)
  • (ID1): 1 Box with 10 Vials(Glass) with 1000 vaccine doses (10000 vaccine doses)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • IDT Biologika GmbH
  • Ceva-Phylaxia Veterinary Biologicals Co. Ltd.
Responsible authority:
  • National Veterinary Medicines Agency
Authorisation number:
  • FR/V/7953262 0/2021
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0208/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 2/03/2022
Updated on: 17/11/2023
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French (PDF)
Published on: 7/04/2022
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 27/09/2023
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