Veterinary Medicines

Tetracure 200 mg/ml solution for injection for cattle, sheep and pigs

Authorised
  • Oxytetracycline dihydrate
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Product identification

Medicine name:
Tetracure 200 mg/ml solution for injection for cattle, sheep and pigs
TETROXYVET 200 mg/ml SOLUCION INYECTABLE PARA BOVINO OVINO Y PORCINO
Active substance:
  • Oxytetracycline dihydrate
Target species:
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Oxytetracycline dihydrate
    216.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        31
        day
      • Milk
        10
        day
    • Sheep
      • Meat and offal
        9
        day
      • Milk
        7
        day
    • Pig
      • Meat and offal
        18
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01AA06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:
  • Amber type II glass vial of 100 ml sealed with a bromobutyl rubber stopper with aluminium overseal and packaged individually into outer carton.

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:
  • Bimeda Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma B.V.
Responsible authority:
  • The Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 3380 ESP
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0440/001
Concerned member states:
  • France
  • Germany
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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Spanish (PDF)
Published on: 16/03/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/02/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 16/03/2023
Download
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