Veterinary Medicines

Enteroporc Coli AC (--) - Lyophilisate and suspension for suspension for injection

Authorised
  • Clostridium perfringens, type A, alpha toxoid
  • Clostridium perfringens, type A, beta2 toxoid
  • Clostridium perfringens, type C, beta1 toxoid
  • Escherichia coli, fimbrial adhesin F4ab
  • Escherichia coli, fimbrial adhesin F4ac
  • Escherichia coli, fimbrial adhesin F5
  • Escherichia coli, fimbrial adhesin F6
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Product identification

Medicine name:
Enteroporc Coli AC (--) - Lyophilisate and suspension for suspension for injection
Active substance:
  • Clostridium perfringens, type A, alpha toxoid
  • Clostridium perfringens, type A, beta2 toxoid
  • Clostridium perfringens, type C, beta1 toxoid
  • Escherichia coli, fimbrial adhesin F4ab
  • Escherichia coli, fimbrial adhesin F4ac
  • Escherichia coli, fimbrial adhesin F5
  • Escherichia coli, fimbrial adhesin F6
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Clostridium perfringens, type A, alpha toxoid
    Presentation_strength:≥ 125 rU Reference:Hse Comments:in lyophilisate Index:0
  • Clostridium perfringens, type A, beta2 toxoid
    Presentation_strength:≥ 794 rU Reference:Hse Comments:in lyophilisate Index:1
  • Clostridium perfringens, type C, beta1 toxoid
    Presentation_strength:≥ 3354 rU Reference:Hse Comments:in lyophilisate Index:2
  • Escherichia coli, fimbrial adhesin F4ab
    Presentation_strength:≥ 23 rU Reference:Hse Comments:in suspension Index:3
  • Escherichia coli, fimbrial adhesin F4ac
    Presentation_strength:≥ 19 rU Reference:Hse Comments:in suspension Index:4
  • Escherichia coli, fimbrial adhesin F5
    Presentation_strength:≥ 13 rU Reference:Hse Comments:in suspension Index:5
  • Escherichia coli, fimbrial adhesin F6
    Presentation_strength:≥ 37 rU Reference:Hse Comments:in suspension Index:6
Pharmaceutical form:
  • Lyophilisate and suspension for suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Not applicable
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB08
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:Lyophilisate: vial (glass); suspension: vial (PET), Package_size:Lyophilisate: 1 vial; suspension: 1 vial, Content:Lyophilisate: 10 ml (25 doses); suspension: 50 ml
  • Packaging:Lyophilisate: vial (glass); suspension: vial (glass), Package_size:Lyophilisate: 1 vial; suspension: 1 vial, Content:Lyophilisate: 10 ml (25 doses); suspension: 50 ml
  • Packaging:Lyophilisate: vial (glass); suspension: vial (PET), Package_size:Lyophilisate: 1 vial; suspension: 1 vial, Content:Lyophilisate: 10 ml (10 doses); suspension: 20 ml
  • Packaging:Lyophilisate: vial (glass); suspension: vial (glass), Package_size:Lyophilisate: 1 vial; suspension: 1 vial, Content:Lyophilisate: 10 ml (10 doses); suspension: 20 ml
  • Packaging:Lyophilisate: vial (glass); suspension: vial (LDPE), Package_size:Lyophilisate: 1 vial; suspension: 1 vial, Content:Lyophilisate: 10 ml (25 doses); suspension: 50 ml

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:
  • CEVA Santé Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • IDT Biologika GmbH
  • 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: 5/12/2024
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Bulgarian (PDF)
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Croatian (PDF)
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Czech (PDF)
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Danish (PDF)
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Dutch (PDF)
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Estonian (PDF)
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Finnish (PDF)
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French (PDF)
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German (PDF)
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Greek (PDF)
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Hungarian (PDF)
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Icelandic (PDF)
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Italian (PDF)
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Latvian (PDF)
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Lithuanian (PDF)
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Maltese (PDF)
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Norwegian (PDF)
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Polish (PDF)
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Portuguese (PDF)
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Romanian (PDF)
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Slovak (PDF)
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Slovenian (PDF)
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Spanish (PDF)
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Swedish (PDF)
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ema-puar-enteroporc-coli-ac-v-5149-par-en.pdf

English (PDF)
Published on: 14/03/2023
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