Authorised

Product identification

Medicine name:
Rabadrop, Oral suspension
Rabadrop, Perorální suspenze
Active substance:
  • Rabies virus, strain SAD, Live
Target species:
  • Fox
  • Raccoon dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Rabies virus, strain SAD, Live
    8.50
    log10 tissue culture infective dose 50
    /
    1.00
    Dose
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Fox
    • Raccoon dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI07BD
Authorisation status:
  • Valid
Authorised in:
  • Czechia
Package description:
  • Plastic Sachet 2 x 350.0 Dose
  • Plastic Sachet 1 x 700.0 Dose
  • Plastic Sachet 1 x 30.0 Dose
  • Paper Box 30 x 20.0 Dose
  • Paper Box 1 x 20.0 Dose

Additional information

Entitlement type:
  • Marketing Authorisation
Marketing authorisation holder:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicines
Authorisation number:
  • 97/047/19-C
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0149/001
Concerned member states:
  • Bulgaria
  • Croatia
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Slovakia
  • Slovenia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/05/2022
Download
Czech (PDF)
Published on: 24/05/2022

Package Leaflet

English (PDF)
Published on: 24/05/2022
Download
Czech (PDF)
Published on: 24/05/2022

Labelling

English (PDF)
Published on: 24/05/2022
Download
Czech (PDF)
Published on: 24/05/2022

eu-puar-czv0149001-mr-rabadrop-en.pdf

English (PDF)
Published on: 16/11/2023
Download

Source URL: https://medicines.health.europa.eu/veterinary/600000054526