Veterinary Medicines

FILAVAC VHD K C+V SUSPENSION FOR INJECTION FOR RABBITS

Authorised
  • Rabbit haemorrhagic disease virus 1, strain IM.507.SC.2011, Inactivated
  • Rabbit haemorrhagic disease virus 2, strain LP.SV.2012, Inactivated
Download as PDF

Product identification

Medicine name:
FILAVAC VHD K C+V SUSPENSION FOR INJECTION FOR RABBITS
Filavac VHD K C+V suspensie voor injectie voor konijnen
Active substance:
  • Rabbit haemorrhagic disease virus 1, strain IM.507.SC.2011, Inactivated
  • Rabbit haemorrhagic disease virus 2, strain LP.SV.2012, Inactivated
Target species:
  • Rabbit
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Rabbit haemorrhagic disease virus 1, strain IM.507.SC.2011, Inactivated
    1.00
    90% protective dose
    /
    1.00
    Dose
  • Rabbit haemorrhagic disease virus 2, strain LP.SV.2012, Inactivated
    1.00
    90% protective dose
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Rabbit
      • All relevant tissues
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI08AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:

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:
  • Filavie
Marketing authorisation date:
Manufacturing sites for batch release:
  • Filavie
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 120127
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0315/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • Germany
  • Greece
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 20/06/2022
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."