Veterinary Medicines

Salmovac 440 Lyophilisate for use in drinking water

Authorised
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain 441/014, Live
Download as PDF

Product identification

Medicine name:
Salmovac 440 Lyophilisate for use in drinking water
CEVAC SALMOVAC, lüofilisaat joogivees manustamiseks
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
Authorisation status:
  • Valid
Authorised in:
  • Estonia
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:
  • State Agency Of Medicines
Authorisation number:
  • 2322
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
Download
Estonian (PDF)
Published on: 22/03/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."