Veterinary Medicines

Rocovac Vet. injektionsvæske, emulsion

Authorised
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4), Inactivated
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
  • Porcine rotavirus A, strain OSU 6, Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4), Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
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Product identification

Medicine name:
Rocovac Vet. injektionsvæske, emulsion
Active substance:
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4), Inactivated
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
  • Porcine rotavirus A, strain OSU 6, Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4), Inactivated
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Escherichia coli, serotype O147:K88 (fimbrial adhesin F4), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype K85:987P (fimbrial adhesin F6), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Porcine rotavirus A, strain OSU 6, Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O101:K99 (fimbrial adhesin F5), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O149:K88 (fimbrial adhesin F4), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
  • Escherichia coli, serotype O101:K99 (fimbrial adhesins F5 and F41), Inactivated
    1.00
    relative potency
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Emulsion for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AL02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Similar biological application (Article 13(4) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Salfarm Danmark A/S
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 65679
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Danish (, INJEKTIONSVÆSKE, EMULSION)
Published on: 27/05/2025
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