Veterinary Medicines

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

Authorised
  • Sulfadiazine
  • Trimethoprim
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Product identification

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

Product details

Active substance and strength:
  • Sulfadiazine
    250.00
    milligram(s)
    /
    1.00
    gram(s)
  • Trimethoprim
    50.00
    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:
  • Sweden
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:
  • Swedish Medical Products Agency
Authorisation number:
  • 56307
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

Package Leaflet

English (PDF)
Published on: 26/04/2022
Download
Swedish (PDF)
Published on: 26/04/2022
Download

Summary of Product Characteristics

English (PDF)
Published on: 26/04/2022
Download
Swedish (PDF)
Published on: 26/04/2022
Download
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