Veterinary Medicines

Pergosafe 0.5 mg film-coated tablets for horses

Authorised
  • Pergolide mesilate
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Product identification

Medicine name:
Pergosafe 0.5 mg film-coated tablets for horses
Pergosafe 0,5 mg filmom obalené tablety pre kone
Active substance:
  • Pergolide mesilate
Target species:
  • Horse
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Pergolide mesilate
    0.66
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Film-coated tablet
Withdrawal period by route of administration:
  • Oral use
    • Horse
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN04BC02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Package description:
  • PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (100 tablets)
  • PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (10 tablets)
  • PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (160 tablets)
  • OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (160 tablets)
  • OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (120 tablets)
  • OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (240 tablets)
  • OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (60 tablets)
  • OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (30 tablets)
  • PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (120 tablets)
  • OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (90 tablets)
  • PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (30 tablets)
  • PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (240 tablets)
  • PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (90 tablets)
  • PVC-PE-PVDC-aluminium blisters, containing 10 tablets each, in a carton box (60 tablets)
  • OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (100 tablets)
  • OPA-aluminium-PVC-aluminium blisters, containing 10 tablets each, in a carton box (10 tablets)

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:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
  • Lelypharma B.V.
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/014/DC/22-S
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0357/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 28/03/2023
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Slovak (PDF)
Published on: 23/02/2024
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