Veterinary Medicines

GALLIVAC IB88 NEO EFFERVESCENT TABLET FOR OCULONASAL SUSPENSION

Authorised
  • Avian infectious bronchitis virus, type 793/B, strain CR88121, Live
Download as PDF

Product identification

Medicine name:
GALLIVAC IB88 NEO EFFERVESCENT TABLET FOR OCULONASAL SUSPENSION
GALLIVAC IB88 NEO šumeča tableta za suspenzijo za razprševanje
Active substance:
  • Avian infectious bronchitis virus, type 793/B, strain CR88121, Live
Target species:
  • Chicken (broiler)
Route of administration:
  • Oculonasal use

Product details

Active substance and strength:
  • Avian infectious bronchitis virus, type 793/B, strain CR88121, Live
    4.00
    log 10 50% embryo infective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Effervescent tablet
Withdrawal period by route of administration:
  • Oculonasal use
    • Chicken (broiler)
      • Meat and offal
        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:
  • Slovenia
Package description:
  • Carton box of 1 blister of 10 tablets of 1 000 doses
  • Carton box of 10 blisters of 10 tablets of 2 000 doses
  • Carton box of 10 blisters of 10 tablets of 1 000 doses
  • Carton box of 1 blister of 10 tablets of 2 000 doses

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Boehringer Ingelheim Animal Health France
Marketing authorisation date:
Manufacturing sites for batch release:
  • Boehringer Ingelheim Animal Health France
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0753/001
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0450/001
Concerned member states:
  • Austria
  • Bulgaria
  • Croatia
  • Cyprus
  • Denmark
  • Finland
  • Greece
  • Iceland
  • Slovenia
  • Sweden

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: 8/04/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 8/04/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 8/04/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."