Veterinary Medicines

DRAXXIN PLUS

Authorised
  • Ketoprofen
  • Tulathromycin
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Product identification

Medicine name:
DRAXXIN PLUS
Draxxin Plus 100 mg/ml
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:
  • Netherlands
Available in:
  • Netherlands
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 B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 124969
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

Summary of Product Characteristics

English (PDF)
Published on: 12/04/2023
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Dutch (PDF)
Published on: 6/11/2023
Updated on: 7/11/2023
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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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