Veterinary Medicines

Suibiovac ART Inaktywowane bakterie Bordetella bronchiseptica (BB 4-78) nie mniej niż 8 x 10^9, Inaktywowane bakterie Pasteurella multocida typ D (CECT 4325) nie mniej niż 8 x 10^9, Letalna dermonekrotoksyna Pasteurella multocida (DNT) nie mniej niż 1 µg, Zawiesina do wstrzykiwań

Authorised
  • Bordetella bronchiseptica, strain BB4-78, Inactivated
  • Pasteurella multocida, serogroup D, strain CECT 4325, Inactivated
  • Pasteurella multocida, protein dO (non-toxic derivative of dermonecrotic toxin), recombinant
Download as PDF

Product identification

Medicine name:
Suibiovac ART Inaktywowane bakterie Bordetella bronchiseptica (BB 4-78) nie mniej niż 8 x 10^9, Inaktywowane bakterie Pasteurella multocida typ D (CECT 4325) nie mniej niż 8 x 10^9, Letalna dermonekrotoksyna Pasteurella multocida (DNT) nie mniej niż 1 µg, Zawiesina do wstrzykiwań
Active substance:
  • Bordetella bronchiseptica, strain BB4-78, Inactivated
  • Pasteurella multocida, serogroup D, strain CECT 4325, Inactivated
  • Pasteurella multocida, protein dO (non-toxic derivative of dermonecrotic toxin), recombinant
Target species:
  • Pig
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Bordetella bronchiseptica, strain BB4-78, Inactivated
    8000.00
    million unit(s)/millilitre
    /
    2.00
    millilitre(s)
  • Pasteurella multocida, serogroup D, strain CECT 4325, Inactivated
    8000.00
    million unit(s)/millilitre
    /
    2.00
    millilitre(s)
  • Pasteurella multocida, protein dO (non-toxic derivative of dermonecrotic toxin), recombinant
    1.00
    microgram(s)
    /
    2.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        0
        day
  • Subcutaneous use
    • Pig
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI09AB04
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Informed consent application (Article 13c of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Biowet Drwalew Sp. z o.o.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Laboratorios Ovejero S.A.U.
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2540
Date of authorisation status change: