Veterinary Medicines

Biosuis Entero, Emulsion for injection

Authorised
  • Porcine rotavirus A, strain OSU 6, Inactivated
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4ac), Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
  • Clostridium perfringens, type C, beta toxoid
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Product identification

Medicine name:
Biosuis Entero, Emulsion for injection
Porvaxin Rota+Coli+Clos emulsão injetável
Active substance:
  • Porcine rotavirus A, strain OSU 6, Inactivated
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4ac), Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
  • Clostridium perfringens, type C, beta toxoid
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Porcine rotavirus A, strain OSU 6, Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4ac), Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
    1.00
    relative potency
    /
    1.00
    Dose
  • Clostridium perfringens, type C, beta toxoid
    1.00
    relative potency
    /
    1.00
    Dose
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AL09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • Glass Vial 1 x 10.0 millilitre(s)
  • Glass Vial 1 x 50.0 millilitre(s)
  • Glass Vial 1 x 100.0 millilitre(s)
  • Plastic (HDPE) Vial 1 x 50.0 millilitre(s)
  • Plastic (HDPE) Vial 1 x 100.0 millilitre(s)
  • Plastic (HDPE) Vial 1 x 250.0 millilitre(s)
  • Glass Vial 10 x 10.0 millilitre(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1634/01/24DIVPT
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0184/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

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Published on: 16/10/2024
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