Veterinary Medicines

Rispoval IBR-Marker Vivum, Lyophilisate and diluent for suspension for injection for cattle

Authorised
  • Bovine herpesvirus 1, strain Difivac gE gene-deleted, Live
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Product identification

Medicine name:
Rispoval IBR-Marker Vivum, Lyophilisate and diluent for suspension for injection for cattle
Rispoval IBR-Marker Vivum lyofilisaat en diluent voor suspensie voor injectie voor runderen
Active substance:
  • Bovine herpesvirus 1, strain Difivac gE gene-deleted, Live
Target species:
  • Cattle
  • Cattle (for meat production)
  • Cattle (calf)
  • Cattle (heifer)
  • Cattle (suckling calf)
Route of administration:
  • Nasal use
  • Nasal use

Product details

Active substance and strength:
  • Bovine herpesvirus 1, strain Difivac gE gene-deleted, Live
    10000000.00
    cell culture infective dose 50
    /
    1.00
    Dose
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Nasal use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Cattle (for meat production)
      • Meat and offal
        0
        day
    • Cattle (calf)
      • Meat and offal
        0
        day
    • Cattle (heifer)
      • Meat and offal
        0
        day
    • Cattle (suckling calf)
      • Meat and offal
        0
        day
  • Nasal use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        0
        day
    • Cattle (for meat production)
      • Meat and offal
        0
        day
    • Cattle (calf)
      • Meat and offal
        0
        day
    • Cattle (heifer)
      • Meat and offal
        0
        day
    • Cattle (suckling calf)
      • Meat and offal
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AD01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • (ID2) 50 Dose; 100 millilitre(s): Box (Cardboard) with 1 Bottle (Glass) with 50 Dose and 1 Bottle (Glass) with 100 millilitre(s)
  • (ID1) 10 Dose; 20 millilitre(s): Box (Cardboard) with 1 Bottle (Glass) with 10 Dose and 1 Bottle (Glass) with 20 millilitre(s)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Immunological veterinary medicinal product application (Article 13d of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 8427
Date of authorisation status change:
Reference member state:
  • Germany
Procedure number:
  • DE/V/0022/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Czechia
  • Estonia
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Malta
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • 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: 3/08/2023
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Summary of Product Characteristics

English (PDF)
Published on: 10/02/2022
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