Veterinary Medicines

PROTIVITY LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE

Authorised
  • Mycoplasma bovis, strain N2805-1, Live
Download as PDF

Product identification

Medicine name:
PROTIVITY LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE
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
    Dose
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:
  • Hungary
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 Hungary Kft.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 4364/1/23 NÉBIH ÁTI
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)