Veterinary Medicines

PRIMUN SALMONELLA T Lyophilisate for use in drinking water for chickens

Authorised
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain ST CAL 16 Str+/Rif+/Enr-, Live
Download as PDF

Product identification

Medicine name:
PRIMUN SALMONELLA T Lyophilisate for use in drinking water for chickens
Primun Salmonella T, Lyofilizát pro podání v pitné vodě
Active substance:
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain ST CAL 16 Str+/Rif+/Enr-, Live
Target species:
  • Chicken (pullet for egg production, future layer)
  • Future breeder pullet
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain ST CAL 16 Str+/Rif+/Enr-, Live
    100000000.00
    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 (pullet for egg production, future layer)
      • Meat and offal
        no withdrawal period
      • Eggs
        no withdrawal period
    • Future breeder pullet
      • Meat and offal
        no withdrawal period
      • Eggs
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AE01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • Cardboard box with 1 vial (20 ml) of 1000 doses
  • Cardboard box with 10 vials (20 ml) of 1000 doses
  • Cardboard box with 1 vial (20 ml) of 2000 doses
  • Cardboard box with 10 vials (20 ml) of 2000 doses

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Laboratorios Calier S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Calier S.A.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicines
Authorisation number:
  • 97/010/23-C
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0408/001
Concerned member states:
  • Belgium
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/03/2023
Download
Czech (PDF)
Published on: 26/04/2024
Download

Package Leaflet

English (PDF)
Published on: 24/03/2023
Download
Czech (PDF)
Published on: 26/04/2024
Download

Labelling

English (PDF)
Published on: 24/03/2023
Download
Czech (PDF)
Published on: 26/04/2024
Download

eu-PUAR-primun-salmonella-t-lyophilisate-for-use-in-drinking-water-for-chicken-en.pdf

English (PDF)
Published on: 24/03/2023
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."