Veterinary Medicines

PRIMUN SALMONELLA E

Authorised
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain CAL10 Sm+/Rif+/Ssq-, Live
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Product identification

Medicine name:
PRIMUN SALMONELLA E
PRIMUN SALMONELLA E лиофилизат за прилагане във вода за пиене за пилета
Active substance:
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain CAL10 Sm+/Rif+/Ssq-, 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 Enteritidis, strain CAL10 Sm+/Rif+/Ssq-, Live
    600000000.00
    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:
  • Bulgaria
Package description:
  • cardboard box containing 10 vials (20 ml) of 2.000 doses
  • cardboard box containing 10 vials (20 ml) of 1.000 doses
  • cardboard box containing 1 vial (20 ml) of 2.000 doses
  • cardboard box containing 1 vial (20 ml) of 1.000 doses
  • Cardboard box containing 10 vials (20 ml) of 4000 doses
  • Cardboard box containing 1 vial (20 ml) of 4000 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:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-3262
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0218/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 19/09/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 15/04/2025
Updated on: 14/04/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 19/09/2024
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