Veterinary Medicine Information website

ENTERICOLIX, emulsion for injection for pigs

Authorised
  • Escherichia coli, serotype O141:K85ab (fimbrial adhesin F6), strain P4, Inactivated
  • Escherichia coli, serotype O101 (fimbrial adhesin F5 and F41), strain P10, Inactivated
  • Escherichia coli, serotype O138:K81 (fimbrial adhesin F18ab), strain P5, Inactivated
  • Escherichia coli, serotype O149:K91:H10 (fimbrial adhesin F4ac), strain P6, Inactivated
  • Escherichia coli, serotype O157:H39 (fimbrial adhesin F18ac), strain P9, Inactivated
  • Clostridium perfringens, type C, beta toxoid
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Product identification

Medicine name:
ENTERICOLIX, emulsion for injection for pigs
Active substance:
  • Escherichia coli, serotype O141:K85ab (fimbrial adhesin F6), strain P4, Inactivated
  • Escherichia coli, serotype O101 (fimbrial adhesin F5 and F41), strain P10, Inactivated
  • Escherichia coli, serotype O138:K81 (fimbrial adhesin F18ab), strain P5, Inactivated
  • Escherichia coli, serotype O149:K91:H10 (fimbrial adhesin F4ac), strain P6, Inactivated
  • Escherichia coli, serotype O157:H39 (fimbrial adhesin F18ac), strain P9, Inactivated
  • Clostridium perfringens, type C, beta toxoid
Target species:
  • Pig (sow, multipar)
  • Pig (sow, primipar)
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Escherichia coli, serotype O141:K85ab (fimbrial adhesin F6), strain P4, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O101 (fimbrial adhesin F5 and F41), strain P10, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O138:K81 (fimbrial adhesin F18ab), strain P5, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O149:K91:H10 (fimbrial adhesin F4ac), strain P6, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O157:H39 (fimbrial adhesin F18ac), strain P9, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Clostridium perfringens, type C, beta toxoid
    10.00
    Toxicity unit(s)
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig (sow, multipar)
      • Meat and offal
        0
        day
    • Pig (sow, primipar)
      • Meat and offal
        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:
  • Netherlands
Package description:
  • box containing 1 bottle of 50 ml (25 doses)

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:
  • CZ Vaccines S.A.U.
Marketing authorisation date:
Manufacturing sites for batch release:
  • CZ Vaccines S.A.U.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 115751
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0228/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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Dutch (PDF)
Published on: 18/01/2022
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Summary of Product Characteristics

English (PDF)
Published on: 25/12/2023
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Package Leaflet

English (PDF)
Published on: 25/12/2023
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Labelling

English (PDF)
Published on: 25/12/2023
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eu-PUAR-esv0228001-dcp-entericolix--emulsion-for-injection-for-pigs-en.pdf

English (PDF)
Published on: 25/12/2023
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