Veterinary Medicines

CEVAC TRANSMUNE lyophilisate for suspension for injection with solvent for chickens

Authorised
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Inactivated
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Product identification

Medicine name:
CEVAC TRANSMUNE lyophilisate for suspension for injection with solvent for chickens
CEVAC TRANSMUNE liofilizzato con diluente per sospensione iniettabile per polli
Active substance:
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Inactivated
Target species:
  • Chicken (embryonated eggs)
  • Chicken
Route of administration:
  • In ovo
  • Subcutaneous use

Product details

Active substance and strength:
  • Infectious bursal disease virus, strain Winterfield 2512 (intermediate plus), Inactivated
    0.10
    50% Protective Dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for suspension for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD09
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • Cardboard box with 20 glass vials (Type I) of 13.5 ml containing 8000 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.
  • Cardboard box with 20 glass vials (Type I) of 10 ml containing 5000 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.
  • Cardboard box with 20 glass vials (Type I) of 10 ml containing 4000 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.
  • Cardboard box with 20 glass vials (Type I) of 10 ml containing 2500 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.
  • Cardboard box with 20 glass vials (Type I) of 10 ml containing 2000 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.
  • Cardboard box with single glass vial (Type I) of 13.5 ml containing 8000 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.
  • Cardboard box with single glass vial (Type I) of 10 ml containing 5000 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.
  • Cardboard box with single glass vial (Type I) of 10 ml containing 4000 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.
  • Cardboard box with single glass vial (Type I) of 10 ml containing 2500 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.
  • Cardboard box with single glass vial (Type I) of 10 ml containing 2000 doses, closed with a bromobutyl stopper and sealed with aluminium caps with plastic tear-off centres.

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:
  • Ceva Salute Animale S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Zrt.
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 103966
Date of authorisation status change:
Reference member state:
  • Hungary
Procedure number:
  • HU/V/0141/002
Concerned member states:
  • Bulgaria
  • Cyprus
  • Czechia
  • Estonia
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 26/08/2025
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Italian (PDF)
Published on: 19/09/2023
Updated on: 21/09/2023
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