Veterinary Medicines

Avishield IBD plus, lyophilisate for use in drinking water, for chickens

Authorised
  • Infectious bursal disease virus, strain G6, Live
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Product identification

Medicine name:
Avishield IBD plus, lyophilisate for use in drinking water, for chickens
Avishield IBD Plus, liofilizat pentru utilizare în apa de băut, pentru pui
Active substance:
  • Infectious bursal disease virus, strain G6, Live
Target species:
  • Chicken
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain G6, Live
    1.90
    unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • All relevant tissues
        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:
  • Romania
Package description:
  • Cardboard box with 10 vials of 5,000 doses of vaccine. Colourless glass vials (type I) filled into 10 ml (5000 doses), which are closed with bromobutyl rubber stoppers and sealed with aluminium caps.
  • Cardboard box with 10 vials of 2,500 doses of vaccine. Colourless glass vials (type I) filled into 10 ml (2500 doses), which are closed with bromobutyl rubber stoppers and sealed with aluminium caps.
  • Cardboard box with 10 vials of 1,000 doses of vaccine. Colourless glass vials (type I) filled into 4 ml (1000 doses), which are closed with bromobutyl rubber stoppers and sealed with aluminium caps.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Genera d.d.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 200067
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0311/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

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Romanian (PDF)
Published on: 7/03/2024
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