Veterinary Medicines

Poulvac IB Primer Oral solution or spray solution after reconstitution of the freeze-dried vaccine in water

Authorised
  • Avian infectious bronchitis virus, strain D274, Live
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
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Product identification

Medicine name:
Poulvac IB Primer Oral solution or spray solution after reconstitution of the freeze-dried vaccine in water
Poulvac IB Primer
Active substance:
  • Avian infectious bronchitis virus, strain D274, Live
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
Target species:
  • Chicken
Route of administration:
  • Nebulisation use
  • Intraocular use

Product details

Active substance and strength:
  • Avian infectious bronchitis virus, strain D274, Live
    1000.00
    50% Embryo Infective Dose
    /
    1.00
    Dose
  • Avian infectious bronchitis virus, type Massachusetts, strain H120, Live
    1000.00
    50% Embryo Infective Dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for oral suspension
Withdrawal period by route of administration:
  • Nebulisation use
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
  • Intraocular use
    • Chicken
      • Meat and offal
        0
        day
      • Egg
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • (ID4): 1 Box with 10 Bottle (Glass) with 1000 Dose (10000 Dose)
  • (ID6): 1 Box with 10 Bottle (Glass) with 5000 Dose (50000 Dose)
  • (ID5): 1 Box with 10 Bottles (Glass) with 2500 Dose (25000 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:
  • 167a/88
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0259/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Netherlands
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 9/06/2022
Download
German (PDF)
Published on: 11/02/2022
Download

2603637-parde-20130515.pdf.pdf

English (PDF)
Published on: 17/09/2024
Download
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