Veterinary Medicines

PROTIVITY LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE

Authorised
  • Mycoplasma bovis, strain N2805-1, Live
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Product identification

Medicine name:
PROTIVITY LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE
Protivity Lyophilisat et solvant pour suspension injectable
Protivity Lyofilisaat en oplosmiddel voor suspensie voor injectie
Protivity Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension
Active substance:
  • Mycoplasma bovis, strain N2805-1, Live
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Mycoplasma bovis, strain N2805-1, Live
    2200000.00
    Colony forming unit
    /
    1.00
    unit(s)
Pharmaceutical form:
  • Lyophilisate and solvent for suspension for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • All relevant tissues
        0
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QI02AE05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Available in:
  • Belgium
Package description:
  • Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 20 ml solvent.

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:
  • Zoetis Belgium
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V661554
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0454/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 12/09/2023
Updated on: 14/09/2023
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French (PDF)
Published on: 12/09/2023
Updated on: 14/09/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 12/09/2023
Updated on: 14/09/2023
Download
French (PDF)
Published on: 12/09/2023
Updated on: 14/09/2023
Download
German (PDF)
Published on: 12/09/2023
Updated on: 14/09/2023
Download