Veterinary Medicines

ESPACOX

Authorised
  • Toltrazuril
Download as PDF

Product identification

Medicine name:
ESPACOX
Espacox 50 mg/ml oral suspension
Active substance:
  • Toltrazuril
Target species:
  • Pig (piglet)
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Toltrazuril
    50.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral suspension
Withdrawal period by route of administration:
  • Oral use
    • Pig (piglet)
      • Meat and offal
        73
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51AJ01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Available in:
  • Denmark
Package description:
  • bottle of 1 L
  • Cardboard box with 1 bottle of 250 ml

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:
  • Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
  • aniMedica GmbH
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 52427
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0206/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
Download
Danish (PDF)
Published on: 29/06/2023
Download

Package Leaflet

English (PDF)
Published on: 22/12/2023
Download

Labelling

English (PDF)
Published on: 22/12/2023
Download

eu-PUAR-esv0206001-dcp-espacox-en.pdf

English (PDF)
Published on: 22/12/2023
Download
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