Veterinary Medicines

FILAVAC VHD K C+V SUSPENSION FOR INJECTION FOR RABBITS

Authorised
  • Rabbit haemorrhagic disease virus, type 1, strain IM.507.SC.2011, Inactivated
  • Rabbit haemorrhagic disease virus, type 2, strain LP.SV.2012, Inactivated
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Product identification

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

Product details

Active substance and strength:
  • Rabbit haemorrhagic disease virus, type 1, strain IM.507.SC.2011, Inactivated
    1.00
    90% protective dose
    /
    1.00
    Dose
  • Rabbit haemorrhagic disease virus, type 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:
  • Denmark
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:
  • Danish Medicines Agency
Authorisation number:
  • 58615
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

Summary of Product Characteristics

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Danish (PDF)
Published on: 11/12/2023
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