Veterinary Medicines

Diatrim 200 mg/ml + 40 mg/ml solution for injection for cattle, pigs, dogs and cats

Authorised
  • Trimethoprim
  • Sulfadiazine
Download as PDF

Product identification

Medicine name:
Diatrim 200 mg/ml + 40 mg/ml solution for injection for cattle, pigs, dogs and cats
Diatrim 200 mg/ml Oplossing voor injectie
Diatrim 200 mg/ml Solution injectable
Diatrim 200 mg/ml Injektionslösung
Active substance:
  • Trimethoprim
  • Sulfadiazine
Target species:
  • Cattle
  • Pig
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Subcutaneous use

Product details

Active substance and strength:
  • Trimethoprim
    40.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Sulfadiazine
    200.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Milk
        48
        hour
      • Meat and offal
        12
        day
    • Pig
      • Meat and offal
        20
        day
  • Subcutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01EW10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Belgium
Package description:
  • 1 vial in a cardboard box of uncoloured glass type II filled with 250 ml with a fluoropolymer coated chlorobutyl stopper type I secured with an aluminium cap.
  • 1 vial in a cardboard box of uncoloured glass type II filled with 50 ml with a fluoropolymer coated chlorobutyl stopper type I secured with an aluminium cap.
  • 1 vial in a cardboard box of uncoloured glass type II filled with 100 ml with a fluoropolymer coated chlorobutyl stopper type I secured with an aluminium cap.

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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V526693
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0282/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • France
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Lithuania
  • Luxembourg
  • Poland
  • Portugal
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 17/08/2025
Download
French (PDF)
Published on: 17/08/2025
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/06/2025
Download
French (PDF)
Published on: 18/06/2025
Download
German (PDF)
Published on: 18/06/2025
Download

Combined File of all Documents

English (PDF)
Published on: 1/02/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 18/06/2025
Download
French (PDF)
Published on: 18/06/2025
Download
German (PDF)
Published on: 18/06/2025
Download

Diatrim - PuAR.pdf

English (PDF)
Published on: 1/02/2024
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."