Enteroporc Coli AC (--) - Lyophilisate and suspension for suspension for injection
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
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 toxoidPresentation_strength:≥ 125 rU Reference:Hse Comments:in lyophilisate Index:0
-
Clostridium perfringens, type A, beta2 toxoidPresentation_strength:≥ 794 rU Reference:Hse Comments:in lyophilisate Index:1
-
Clostridium perfringens, type C, beta1 toxoidPresentation_strength:≥ 3354 rU Reference:Hse Comments:in lyophilisate Index:2
-
Escherichia coli, fimbrial adhesin F4abPresentation_strength:≥ 23 rU Reference:Hse Comments:in suspension Index:3
-
Escherichia coli, fimbrial adhesin F4acPresentation_strength:≥ 19 rU Reference:Hse Comments:in suspension Index:4
-
Escherichia coli, fimbrial adhesin F5Presentation_strength:≥ 13 rU Reference:Hse Comments:in suspension Index:5
-
Escherichia coli, fimbrial adhesin F6Presentation_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 applicable0dayZero days
-
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
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 Veterinary Biologicals Co. Ltd.
Responsible authority:
- European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 8/11/2022
Bulgarian (PDF)
Published on: 8/11/2022
Croatian (PDF)
Published on: 8/11/2022
Czech (PDF)
Published on: 8/11/2022
Danish (PDF)
Published on: 8/11/2022
Dutch (PDF)
Published on: 8/11/2022
Estonian (PDF)
Published on: 8/11/2022
Finnish (PDF)
Published on: 8/11/2022
French (PDF)
Published on: 8/11/2022
German (PDF)
Published on: 8/11/2022
Greek (PDF)
Published on: 8/11/2022
Hungarian (PDF)
Published on: 8/11/2022
Icelandic (PDF)
Published on: 8/11/2022
Italian (PDF)
Published on: 8/11/2022
Latvian (PDF)
Published on: 8/11/2022
Lithuanian (PDF)
Published on: 8/11/2022
Maltese (PDF)
Published on: 8/11/2022
Norwegian (PDF)
Published on: 8/11/2022
Polish (PDF)
Published on: 8/11/2022
Portuguese (PDF)
Published on: 8/11/2022
Romanian (PDF)
Published on: 8/11/2022
Slovak (PDF)
Published on: 8/11/2022
Slovenian (PDF)
Published on: 8/11/2022
Spanish (PDF)
Published on: 8/11/2022
Swedish (PDF)
Published on: 8/11/2022
ema-puar-enteroporc-coli-ac-v-5149-par-en.pdf
English (PDF)
Download Published on: 14/03/2023
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