Veterinary Medicines

Tulaject 25 mg/ml solution for injection for Pigs

Not authorised
  • Tulathromycin
Download as PDF

Product identification

Medicine name:
Tulaject 25 mg/ml solution for injection for Pigs
Tulaject 25 mg/ml oplossing voor injectie voor varkens
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:
  • Surrendered
Authorised 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:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Alivira Animal Health Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Bremer Pharma GmbH
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 125828
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0372/001

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 2/02/2022
Download

eu-PUAR-tulaject-25-mg-ml-solution-for-injection-for-pigs-en.pdf

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