Veterinary Medicine Information website

CEVAC MASS L lyophilisate for oculonasal suspension for chickens

Authorised
  • Infectious bronchitis virus, type Massachusetts, strain B-48, Live
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Product identification

Medicine name:
CEVAC MASS L lyophilisate for oculonasal suspension for chickens
Active substance:
  • Infectious bronchitis virus, type Massachusetts, strain B-48, Live
Target species:
  • Chicken (broiler)
Route of administration:
  • Nebulisation use

Product details

Active substance and strength:
  • Infectious bronchitis virus, type Massachusetts, strain B-48, Live
    4.30
    log 10 50% embryo infective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate for oculonasal suspension
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI01AD07
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
Package description:
  • The vaccine is supplied in 3 or 10 ml type I glass vials, sealed with bromobutyl rubber stoppers and aluminium caps with plastic (flip-off) tops. 1x1000 dose.
  • The vaccine is supplied in 3 or 10 ml type I glass vials, sealed with bromobutyl rubber stoppers and aluminium caps with plastic (flip-off) tops. 1x2500 dose.
  • The vaccine is supplied in 3 or 10 ml type I glass vials, sealed with bromobutyl rubber stoppers and aluminium caps with plastic (flip-off) tops. 1x5000 dose.
  • The vaccine is supplied in 3 or 10 ml type I glass vials, sealed with bromobutyl rubber stoppers and aluminium caps with plastic (flip-off) tops. 10x1000 dose.
  • The vaccine is supplied in 3 or 10 ml type I glass vials, sealed with bromobutyl rubber stoppers and aluminium caps with plastic (flip-off) tops. 10x2500 dose.
  • The vaccine is supplied in 3 or 10 ml type I glass vials, sealed with bromobutyl rubber stoppers and aluminium caps with plastic (flip-off) tops. 10x5000 dose.
  • The vaccine is supplied in 3 or 10 ml type I glass vials, sealed with bromobutyl rubber stoppers and aluminium caps with plastic (flip-off) tops. 20x1000 dose.
  • The vaccine is supplied in 3 or 10 ml type I glass vials, sealed with bromobutyl rubber stoppers and aluminium caps with plastic (flip-off) tops. 20x2500 dose.
  • The vaccine is supplied in 3 or 10 ml type I glass vials, sealed with bromobutyl rubber stoppers and aluminium caps with plastic (flip-off) tops. 20x5000 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:
  • Ceva-Phylaxia Zrt.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva-Phylaxia Zrt.
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0546/001
Date of authorisation status change:
Reference member state:
  • Hungary
Procedure number:
  • HU/V/0125/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 9/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 9/03/2022
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 9/03/2022
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Combined File of all Documents

English (PDF)
Published on: 27/08/2025
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