Veterinary Medicines

Prednizol 5mg Tablets for Dogs and Cats

Authorised
  • Prednisolone
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Product identification

Medicine name:
Prednizol 5mg Tablets for Dogs and Cats
Prednizol 5 mg tabletten voor honden en katten
Active substance:
  • Prednisolone
Target species:
  • Dog
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Prednisolone
    5.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02AB06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Netherlands
Package description:
  • Cardboard box of 1 PVC Aluminium/PVC foil blister of 10 tablets each
  • White polypropylene container containing 250 tablets, sealed with a white, childresistant, high-density polyethylene closure.
  • Cardboard box of 2 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 3 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 4 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 5 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 6 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 7 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 8 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 9 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 10 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 12 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 15 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 25 PVC Aluminium/PVC foil blisters of 10 tablets each
  • Cardboard box of 50 PVC Aluminium/PVC foil blisters of 10 tablets each

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:
  • Millpledge Europe
Marketing authorisation date:
Manufacturing sites for batch release:
  • Millpledge Europe
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 122989
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0351/001
Concerned member states:
  • Belgium
  • France
  • Germany
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 1/11/2023
Updated on: 2/11/2023
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Dutch (PDF)
Published on: 8/11/2023
Updated on: 13/11/2023
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