Veterinary Medicines

Enzaprost Bovis 12.5 mg/ml solution for injection for cattle

Not authorised
  • Dinoprost trometamol
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Product identification

Medicine name:
Enzaprost Bovis 12.5 mg/ml solution for injection for cattle
Enzaprost Bovis 12,5 mg/ml Injektionslösung für Rinder
Active substance:
  • Dinoprost trometamol
Target species:
  • Cattle
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Dinoprost trometamol
    12.50
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        0
        day
      • Meat and offal
        2
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QG02AD01
Legal status of supply:
  • Medicinal product on medical prescription for non-renewable delivery
Authorisation status:
  • Revoked
Authorised in:
  • Austria
Package description:
  • Cardboard box containing 1 translucent multi layer (polypropylene _ethylene vinyl alcohol _polypropylene) vial of 100 closed with a bromobutyl rubber stopper and aluminium and plastic flip capsule
  • Cardboard box containing 1 colourless type I glass vial of 20 ml closed with a bromobutyl rubber stopper and aluminium and plastic flip capsule
  • Cardboard box containing 1 colourless type I glass vial of 2 ml closed with a bromobutyl rubber stopper and aluminium and plastic flip capsule
  • Cardboard box containing 1 colourless type I glass vial of 10 ml closed with a bromobutyl rubber stopper and aluminium and plastic flip capsule
  • Cardboard box containing 1 translucent multi layer (polypropylene _ethylene vinyl alcohol _polypropylene) vial of 50 closed with a bromobutyl rubber stopper and aluminium and plastic flip capsule
  • Cardboard box containing 10 colourless type I glass vial of 2 ml closed with a bromobutyl rubber stopper and aluminium and plastic flip capsule

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Ceva Sante Animale
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 840506
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0256/001

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 8/02/2021
Updated on: 19/01/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 8/02/2021
Updated on: 19/01/2024
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 8/02/2021
Updated on: 19/01/2024
Download
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