Veterinary Medicines

Sulfequine 333 mg/g + 67 mg/g oral paste for horses

Authorised
  • Sulfadiazine
  • Trimethoprim
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Product identification

Medicine name:
Sulfequine 333 mg/g + 67 mg/g oral paste for horses
Sulfequine (333 mg + 67 mg)/ml Pasta doustna
Active substance:
  • Sulfadiazine
  • Trimethoprim
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Sulfadiazine
    333.00
    milligram(s)
    /
    1.00
    gram(s)
  • Trimethoprim
    67.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral paste
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        15
        day
      • Meat and offal
        6
        month
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01EW10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Poland
Package description:
  • Cardboard box containing 1 oral syringe containing 45 grams paste
  • Cardboard box containing 5 oral syringes containing 45 grams paste
  • Cardboard box containing 6 oral syringes containing 45 grams paste
  • Cardboard box containing 10 oral syringes containing 45 grams paste
  • Cardboard box containing 1 oral syringe containing 52.5 grams paste
  • Cardboard box containing 5 oral syringes containing 52.5 grams paste
  • Cardboard box containing 6 oral strings containing 52.5 grams paste
  • Cardboard box containing 10 oral syringes containing 52.5 grams paste

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 19(1) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3432
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0428/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • 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.
Polish (PDF)
Published on: 18/08/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 18/08/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 18/08/2025
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Public Assessment Report - Sulfequine - NL-V-0428-001-DC final.pdf

English (PDF)
Published on: 18/09/2025
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