Veterinary Medicines

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
Download as PDF

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:
  • Medicinal product subject to medical 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
Download
Bulgarian (PDF)
Published on: 16/10/2024
Download
Croatian (PDF)
Published on: 16/10/2024
Download
Czech (PDF)
Published on: 16/10/2024
Download
Danish (PDF)
Published on: 16/10/2024
Download
Dutch (PDF)
Published on: 16/10/2024
Download
Finnish (PDF)
Published on: 16/10/2024
Download
French (PDF)
Published on: 16/10/2024
Download
German (PDF)
Published on: 16/10/2024
Download
Greek (PDF)
Published on: 16/10/2024
Download
Hungarian (PDF)
Published on: 16/10/2024
Download
Icelandic (PDF)
Published on: 16/10/2024
Download
Italian (PDF)
Published on: 16/10/2024
Download
Lithuanian (PDF)
Published on: 16/10/2024
Download
Maltese (PDF)
Published on: 16/10/2024
Download
Norwegian (PDF)
Published on: 16/10/2024
Download
Polish (PDF)
Published on: 16/10/2024
Download
Portuguese (PDF)
Published on: 16/10/2024
Download
Slovak (PDF)
Published on: 16/10/2024
Download
Slovenian (PDF)
Published on: 16/10/2024
Download
Spanish (PDF)
Published on: 16/10/2024
Download
Swedish (PDF)
Published on: 16/10/2024
Download

ema-puar-v6118-cevacsalmuneetik-en.pdf

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