Veterinary Medicines

Equipalazone 1 g Oral powder

Authorised
  • Phenylbutazone
Download as PDF

Product identification

Medicine name:
Fenylbutazon Dechra Vet 1 g pulver til hest og ponni
Equipalazone 1 g Oral powder
Active substance:
  • Phenylbutazone
Target species:
  • Horse (pony)
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Phenylbutazone
    1.00
    gram(s)
    /
    1.00
    Sachet
Pharmaceutical form:
  • Oral powder
Withdrawal period by route of administration:
  • Oral use
    • Horse (pony)
      • Meat and offal
        no withdrawal period
    • Horse
      • Meat and offal
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Package description:
  • Equipalazone 1 g or. pwdr. sachet 100
  • Equipalazone 1 g or. pwdr. sachet 32

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 16-11233
Date of authorisation status change:
Reference member state:
  • Belgium
Procedure number:
  • BE/V/0037/001
Concerned member states:
  • Austria
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 20/11/2024
Download

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: 20/11/2024
Download