Veterinary Medicines

Poulvac Bursa Plus Lyophilisate for suspension in drinking water

Authorised
  • Infectious bursal disease virus, strain V877 (intermediate plus), Live
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Product identification

Medicine name:
Poulvac Bursa Plus Lyophilisate for suspension in drinking water
Poulvac Bursa Plus
Active substance:
  • Infectious bursal disease virus, strain V877 (intermediate plus), Live
Target species:
  • Chicken
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain V877 (intermediate plus), Live
    158.00
    50% Embryo Infective Dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • Egg
        0
        day
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Available in:
  • Germany
Package description:
  • (ID6): 1 Box with 10 Bottle (Glass) with 5000 Dose (50000 Dose)
  • (ID5): 1 Box with 10 Bottle (Glass) with 2000 Dose (20000 Dose)
  • (ID4): 1 Box with 10 Bottle (Glass) with 1000 Dose (10000 Dose)
  • (ID3): 1 Box with 1 Bottle (Glass) with 5000 Dose (5000 Dose)
  • (ID2): 1 Box with 1 Bottle (Glass) with 2000 Dose (2000 Dose)
  • (ID1): 1 Box with 1 Bottle (Glass) with 1000 Dose (1000 Dose)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis Deutschland GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Paul-Ehrlich-Institut
Authorisation number:
  • PEI.V.04760.01.1
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0278/001
Concerned member states:
  • Belgium
  • Greece
  • Ireland
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovenia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 9/08/2022
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German (PDF)
Published on: 10/02/2022
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