Veterinary Medicines

BioRabbit RHDV 1,2, Suspension for injection

Authorised
  • Rabbit haemorrhagic disease virus, type 1, strain Borohradek, Inactivated
  • Rabbit haemorrhagic disease virus, type 2, strain Ceska Lipa, Inactivated
Download as PDF

Product identification

Medicine name:
BioRabbit RHDV 1,2, Suspension for injection
BioRabbit RHDV 1, 2, suspenzija za injekciju, za kuniće
Active substance:
  • Rabbit haemorrhagic disease virus, type 1, strain Borohradek, Inactivated
  • Rabbit haemorrhagic disease virus, type 2, strain Ceska Lipa, Inactivated
Target species:
  • Rabbit
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Rabbit haemorrhagic disease virus, type 1, strain Borohradek, Inactivated
    60.00
    haemagglutination inhibiting unit(s)
    /
    1.00
    Dose
  • Rabbit haemorrhagic disease virus, type 2, strain Ceska Lipa, Inactivated
    80.00
    haemagglutination inhibiting unit(s)
    /
    1.00
    Dose
Pharmaceutical form:
  • Suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Rabbit
      • Meat and offal
        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:
  • Croatia
Package description:
  • Plastic Vial 10 x 20.0 Dose
  • Plastic Vial 10 x 10.0 Dose
  • Plastic Vial 1 x 20.0 Dose
  • Plastic Vial 1 x 10.0 Dose
  • Glass Vial 10 x 20.0 Dose
  • Glass Vial 10 x 10.0 Dose
  • Glass Vial 10 x 1.0 Dose
  • Glass Vial 1 x 20.0 Dose
  • Glass Vial 1 x 10.0 Dose

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - known active substance (Article 8 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Bioveta a.s.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bioveta a.s.
Responsible authority:
  • Ministry Of Agriculture Veterinary And Food Safety Directorate
Authorisation number:
  • UP/I-322-05/23-01/358
Date of authorisation status change:
Reference member state:
  • Czechia
Procedure number:
  • CZ/V/0180/001
Concerned member states:
  • Bulgaria
  • Croatia
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Slovakia
  • Slovenia

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Croatian (PDF)
Published on: 20/06/2023
Updated on: 26/06/2023
Download