Veterinary Medicines

Prasequine 1 mg tablets for horses

Authorised
  • Pergolide
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Product identification

Medicine name:
Prasequine 1 mg tablets for horses
Prasequine, 1 mg tabletid hobustele
Active substance:
  • Pergolide
Target species:
  • Horse (non food-producing)
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Pergolide
    1.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Horse (non food-producing)
      • Not applicable
        no withdrawal period
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN04BC02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Estonia
Package description:
  • Carton box containing 13 OPA/aluminium/PVC-aluminium blisters, containing 7 tablets each
  • Carton box containing 24 OPA/aluminium/PVC-aluminium blisters, containing 10 tablets each
  • Carton box containing 16 OPA/aluminium/PVC-aluminium blisters, containing 10 tablets each
  • Carton box containing 10 OPA/aluminium/PVC-aluminium blisters, containing 10 tablets each
  • Carton box containing 6 OPA/aluminium/PVC-aluminium blisters, containing 10 tablets each

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic (abridged application) - art 13(1)
Marketing authorisation holder:
  • CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • CP-Pharma Handelsgesellschaft mbH
Responsible authority:
  • State Agency Of Medicines
Authorisation number:
  • 1091522
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0368/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 9/05/2023
Updated on: 10/05/2023
Download
Estonian (PDF)
Published on: 31/03/2025
Download

Package Leaflet and Labelling

English (PDF)
Published on: 9/05/2023
Updated on: 10/05/2023
Download
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