Veterinary Medicine Information website

DORAXX 25 mg/ml solution for injection for pigs

Authorised
  • Tulathromycin
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Product identification

Medicine name:
DORAXX 25 mg/ml solution for injection for pigs
Active substance:
  • Tulathromycin
Target species:
  • Pig
Route of administration:
  • Intramuscular use

Product details

Active substance and strength:
  • Tulathromycin
    25.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Pig
      • Meat and offal
        13
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA94
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Cardboard box containing one vial of 100 ml

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:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Mevet S.A.
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/1392076 8/2021
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0402/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 24/03/2023
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French (PDF)
Published on: 7/04/2022
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Package Leaflet

English (PDF)
Published on: 24/03/2023
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Labelling

English (PDF)
Published on: 24/03/2023
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eu-PUAR-doraxx-25-mg-ml-solution-for-injection-for-pigs-en.pdf

English (PDF)
Published on: 24/03/2023
Download