Veterinary Medicines

Equibactin vet. (333 mg/g+67 mg/g) Oral Paste for horses

Authorised
  • Trimethoprim
  • Sulfadiazine
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Product identification

Medicine name:
Equibactin vet. (333 mg/g+67 mg/g) Oral Paste for horses
Equibactin vet. (333 mg/g + 67 mg/g) oralpasta til hest
Active substance:
  • Trimethoprim
  • Sulfadiazine
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Trimethoprim
    66.70
    milligram(s)
    /
    1.00
    gram(s)
  • Sulfadiazine
    333.30
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Oral paste
Withdrawal period by route of administration:
  • Oral use
    • Horse
      • Meat and offal
        14
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01EW10
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Package description:
  • 1 pre-filled multi-dose (Low Density) polyethylene syringe containing 45 g paste with adjustable screw ring closed with a (Low Density) polyethylene cap, packed in a cardboard box.
  • 5 pre-filled multi-dose (Low Density) polyethylene syringes containing 45 g paste with adjustable screw ring closed with a (Low Density) polyethylene cap, packed in a cardboard box.

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:
  • Le Vet. B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 06-4325
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0123/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Luxembourg
  • Norway
  • Portugal
  • 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.
Norwegian (PDF)
Published on: 14/01/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 8/12/2022
Download
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