Veterinary Medicine Information website

Cevac Salmune ETI K (--) - Suspension for injection

Authorised
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain 038-90, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain 076-94, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Infantis, strain SM-595, Inactivated
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Product identification

Medicine name:
Cevac Salmune ETI K (--) - Suspension for injection
Active substance:
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain 038-90, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain 076-94, Inactivated
  • Salmonella enterica, subsp. enterica, serovar Infantis, strain SM-595, Inactivated
Target species:
  • Chicken
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Salmonella enterica, subsp. enterica, serovar Enteritidis, strain 038-90, Inactivated
    Presentation_strength:≥ 122 ELISA units Reference:In house Index:0
  • Salmonella enterica, subsp. enterica, serovar Typhimurium, strain 076-94, Inactivated
    Presentation_strength:≥ 212 ELISA units Reference:In house Index:1
  • Salmonella enterica, subsp. enterica, serovar Infantis, strain SM-595, Inactivated
    Presentation_strength:≥ 157 ELISA units Reference:In house Index:2
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Chicken
      • Not applicable
        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:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Package description:
  • Packaging:Bottle (LDP), Package_size:1 bottle, Content:1000 doses
  • Packaging:Bottle (LDP), Package_size:5 bottles, Content:1000 doses

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - known active substance (Article 8 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • CEVA-Phylaxia Zrt.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Zrt.
Responsible authority:
  • European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

English (PDF)
Published on: 16/10/2024
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Danish (PDF)
Published on: 16/10/2024
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Czech (PDF)
Published on: 16/10/2024
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Greek (PDF)
Published on: 16/10/2024
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German (PDF)
Published on: 16/10/2024
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Bulgarian (PDF)
Published on: 16/10/2024
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Spanish (PDF)
Published on: 16/10/2024
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French (PDF)
Published on: 16/10/2024
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Croatian (PDF)
Published on: 16/10/2024
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Finnish (PDF)
Published on: 16/10/2024
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Italian (PDF)
Published on: 16/10/2024
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Hungarian (PDF)
Published on: 16/10/2024
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Icelandic (PDF)
Published on: 16/10/2024
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Lithuanian (PDF)
Published on: 16/10/2024
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Swedish (PDF)
Published on: 16/10/2024
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Norwegian (PDF)
Published on: 16/10/2024
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Maltese (PDF)
Published on: 16/10/2024
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Slovak (PDF)
Published on: 16/10/2024
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Portuguese (PDF)
Published on: 16/10/2024
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Polish (PDF)
Published on: 16/10/2024
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Slovenian (PDF)
Published on: 16/10/2024
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Dutch (PDF)
Published on: 16/10/2024
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ema-puar-v6118-cevacsalmuneetik-en.pdf

English (PDF)
Published on: 22/01/2025
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