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AZIGAN 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP

Authorised
  • Tulathromycin
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Product identification

Medicine name:
AZIGAN 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP
Active substance:
  • Tulathromycin
Target species:
  • Cattle
  • Sheep
  • Pig
Route of administration:
  • Subcutaneous use
  • Intramuscular use

Product details

Active substance and strength:
  • Tulathromycin
    100.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Subcutaneous use
    • Cattle
      • Meat and offal
        22
        day
    • Cattle
      • Milk
        no withdrawal period
  • Intramuscular use
    • Sheep
      • Meat and offal
        16
        day
    • Pig
      • Meat and offal
        13
        day
    • Sheep
      • Milk
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01FA94
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • box with 1 vial 100 ml
  • box with 1 vial 250 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Global Vet Health S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • S P Veterinaria S.A.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 1673/01/24DFVPT
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0429/001
Concerned member states:
  • Malta
  • Portugal

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 17/03/2026
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Summary of Product Characteristics

English (PDF)
Published on: 14/03/2026
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Package Leaflet

English (PDF)
Published on: 14/03/2026
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Labelling

English (PDF)
Published on: 14/03/2026
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eu-PUAR-esv0429001-dcp-azigan-100-mg-ml-solution-for-injection-for-cattle--pigs-and-sheep-en.pdf

English (PDF)
Published on: 14/03/2026
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