Veterinary Medicines Information website

VeroBlue-3 1000 EU/ml - Lyophilisate and solvent for suspension for injection

Authorised
  • Bluetongue virus, serotype 3, VP2 protein (recombinant)
Download as PDF

Product identification

Medicine name:
VeroBlue-3 1000 EU/ml - Lyophilisate and solvent for suspension for injection
Active substance:
  • Bluetongue virus, serotype 3, VP2 protein (recombinant)
Target species:
  • Sheep
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Bluetongue virus, serotype 3, VP2 protein (recombinant)
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Sheep
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI04AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Liechtenstein
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
Package description:
  • Packaging:Lyophilisate: vial (glass type I); Solvent: vial (glass type I), Package_size:Lyophilisate: 1 vial + solvent: 1 vial, Content:Lyophilisate: 10 doses + solvent: 10 ml
  • Packaging:Lyophilisate: vial (glass type I); Solvent: vial (glass type I), Package_size:Lyophilisate: 1 vial + solvent: 1 vial, Content:Lyophilisate: 5 doses + solvent: 5 ml
  • Packaging:Lyophilisate: vial (glass type I); Solvent: vial (glass type I), Package_size:Lyophilisate: 1 vial + solvent: 1 vial, Content:Lyophilisate: 50 doses + solvent: 50 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • New active substance - Exceptional circumstances (Article 25 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • VEROVACCiNES GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biovet AD
Responsible authority:
  • European Commission
Authorisation number:
This information is not available for this product.
Date of authorisation status change:

Documents

Combined File of all Documents

English (PDF)
Published on: 26/08/2026
Download
Croatian (PDF)
Published on: 26/08/2026
Download
Hungarian (PDF)
Published on: 26/08/2026
Download
Bulgarian (PDF)
Published on: 26/08/2026
Download
Czech (PDF)
Published on: 26/08/2026
Download
Danish (PDF)
Published on: 26/08/2026
Download
German (PDF)
Published on: 26/08/2026
Download
Greek (PDF)
Published on: 26/08/2026
Download
French (PDF)
Published on: 26/08/2026
Download
Spanish (PDF)
Published on: 26/08/2026
Download
Estonian (PDF)
Published on: 26/08/2026
Download
Finnish (PDF)
Published on: 26/08/2026
Download
Icelandic (PDF)
Published on: 26/08/2026
Download
Italian (PDF)
Published on: 26/08/2026
Download
Lithuanian (PDF)
Published on: 26/08/2026
Download
Latvian (PDF)
Published on: 26/08/2026
Download
Maltese (PDF)
Published on: 26/08/2026
Download
Dutch (PDF)
Published on: 26/08/2026
Download
Norwegian (PDF)
Published on: 26/08/2026
Download
Polish (PDF)
Published on: 26/08/2026
Download
Portuguese (PDF)
Published on: 26/08/2026
Download
Romanian (PDF)
Published on: 26/08/2026
Download
Slovak (PDF)
Published on: 26/08/2026
Download
Slovenian (PDF)
Published on: 26/08/2026
Download
Swedish (PDF)
Published on: 26/08/2026
Download

ema-puar-v6821-veroblue3-initial-en.pdf

English (PDF)
Published on: 23/09/2026
Download