Veterinary Medicines

Gallimune Se + St, water-in-oil emulsion for injection

Authorised
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain DT104, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain PT4, Inactivated
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Product identification

Medicine name:
Gallimune Se + St, water-in oil emulsion for injection
Gallimune Se + St, water-in-oil emulsion for injection
Active substance:
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain DT104, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain PT4, Inactivated
Target species:
  • Chicken (pullet)
  • Chicken
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain DT104, Inactivated
    149.00
    antibody unit(s)
    /
    0.30
    millilitre(s)
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain PT4, Inactivated
    171.00
    antibody unit(s)
    /
    0.30
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Chicken (pullet)
      • Meat and offal
        0
        day
      • Egg
        0
        day
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AB01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Ireland
Package description:
  • (ID2) 3000 millilitre(s): Box with 10 Bottle (PolyPropylene) each with 300 millilitre(s), closed with Closure and Cap (Acrylnitril-Butadien-Kautschuk, Aluminium)
  • (ID1) 300 millilitre(s): Box with 1 Bottle (PolyPropylene) with 300 millilitre(s), closed with Closure and Cap (Acrylnitril-Butadien-Kautschuk, Aluminium)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Vetmedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health Italia S.p.A. In Breve Boehringer Ingelheim Ah It S.p.A.
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10454/054/001
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0282/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Denmark
  • France
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 10/02/2022
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