Veterinary Medicines

DRAXXIN PLUS

Authorised
  • Ketoprofen
  • Tulathromycin
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Product identification

Medicine name:
DRAXXIN PLUS
Draxxin plus 100 mg/ml + 120 mg/ml ενέσιμο διάλυμα για βοοειδή
Active substance:
  • Ketoprofen
  • Tulathromycin
Target species:
  • Cattle
Route of administration:
  • Subcutaneous use

Product details

Active substance and strength:
  • Ketoprofen
    120.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Tulathromycin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Milk
        no withdrawal period
      • Meat and offal
        50
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Cyprus
Available in:
  • Cyprus
Package description:
  • cardboard box containing 1 vial of 250 ml
  • cardboard box containing 1 vial of 100 ml
  • cardboard box containing 1 vial of 50 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Fixed combination application (Article 13b of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Zoetis Hellas S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Veterinary Services, Ministry Of Agriculture, Natural Resources And Environment
Authorisation number:
  • CY00790V
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0352/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • 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.
Greek (PDF)
Published on: 4/04/2025
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Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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Package Leaflet

English (PDF)
Published on: 12/04/2023
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Labelling

English (PDF)
Published on: 12/04/2023
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eu-PUAR-draxxin-plus-en.pdf

English (PDF)
Published on: 12/04/2023
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