Veterinary Medicines

Equibactin vet. 250 mg/g + 50 mg/g, oral powder

Authorised
  • Trimethoprim
  • Sulfadiazine
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Product identification

Medicine name:
Equibactin vet. 250 mg/g + 50 mg/g, oral powder
Equibactin 250 mg/g + 50 mg/g perorálny prášok pre kone
Active substance:
  • Trimethoprim
  • Sulfadiazine
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Trimethoprim
    50.00
    milligram(s)
    /
    1.00
    gram(s)
  • Sulfadiazine
    250.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral powder
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        20
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01EW10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Package description:

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:
  • Lelypharma B.V.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/022/DC/20-S
Date of authorisation status change:
Reference member state:
  • Sweden
Procedure number:
  • SE/V/0120/001
Concerned member states:
  • Austria
  • Belgium
  • Croatia
  • Cyprus
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 2/02/2022
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Summary of Product Characteristics

English (PDF)
Published on: 28/07/2025
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Package Leaflet

English (PDF)
Published on: 28/07/2025
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Labelling

English (PDF)
Published on: 28/07/2025
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