Veterinary Medicines

Fatrovax RHD (--) - Suspension for injection

Authorised
  • Rabbit haemorrhagic disease virus, type 1, capsid protein VP60a
  • Rabbit haemorrhagic disease virus, type 2, capsid protein VP60ab
Download as PDF

Product identification

Medicine name:
Fatrovax RHD (--) - Suspension for injection
Active substance:
  • Rabbit haemorrhagic disease virus, type 1, capsid protein VP60a
  • Rabbit haemorrhagic disease virus, type 2, capsid protein VP60ab
Target species:
  • Rabbit
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Rabbit haemorrhagic disease virus, type 1, capsid protein VP60a
    Presentation_strength:≥1 RP Index:2
  • Rabbit haemorrhagic disease virus, type 2, capsid protein VP60ab
    Presentation_strength:≥1 RP Index:3
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Rabbit
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI08AA01
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:Bottle (PP), Package_size:1 bottle, Content:100 ml (200 doses)
  • Packaging:Bottle (PP), Package_size:1 bottle, Content:25 ml (50 doses)
  • Packaging:Syringe (glass), Package_size:5 pre-filled syringes of 1 dose, Content:0.5 ml (1 dose)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Fatro S.p.A
Marketing authorisation date:
Manufacturing sites for batch release:
  • Fatro S.p.A.
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: 26/08/2024
Download
Bulgarian (PDF)
Published on: 26/08/2024
Download
Croatian (PDF)
Published on: 26/08/2024
Download
Czech (PDF)
Published on: 26/08/2024
Download
Danish (PDF)
Published on: 26/08/2024
Download
Dutch (PDF)
Published on: 26/08/2024
Download
Estonian (PDF)
Published on: 26/08/2024
Download
Finnish (PDF)
Published on: 26/08/2024
Download
French (PDF)
Published on: 26/08/2024
Download
German (PDF)
Published on: 26/08/2024
Download
Greek (PDF)
Published on: 26/08/2024
Download
Hungarian (PDF)
Published on: 26/08/2024
Download
Icelandic (PDF)
Published on: 26/08/2024
Download
Italian (PDF)
Published on: 26/08/2024
Download
Latvian (PDF)
Published on: 26/08/2024
Download
Lithuanian (PDF)
Published on: 26/08/2024
Download
Maltese (PDF)
Published on: 26/08/2024
Download
Norwegian (PDF)
Published on: 26/08/2024
Download
Polish (PDF)
Published on: 26/08/2024
Download
Portuguese (PDF)
Published on: 26/08/2024
Download
Romanian (PDF)
Published on: 26/08/2024
Download
Slovak (PDF)
Published on: 26/08/2024
Download
Slovenian (PDF)
Published on: 26/08/2024
Download
Spanish (PDF)
Published on: 26/08/2024
Download
Swedish (PDF)
Published on: 26/08/2024
Download

ema-puar-fatrovax-rhd-v-5301-par-en.pdf

English (PDF)
Published on: 14/03/2023
Download