Veterinary Medicines

Prednicortone 5 mg tablets for dogs and cats

Authorised
  • Prednisolone
Download as PDF

Product identification

Medicine name:
Prednicortone 5 mg tablets for dogs and cats
Prednicortone Vet. 5 mg tabletter
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:
  • Denmark
Package description:
  • Cardboard box of 1 Aluminium - PVC/PE/PVDC blister of 10 tablets.
  • Cardboard box of 5 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 4 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 3 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 15 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 25 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 2 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 10 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 8 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 7 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 6 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 50 Aluminium - PVC/PE/PVDC blisters of 10 tablets.
  • Cardboard box of 9 Aluminium - PVC/PE/PVDC blisters of 10 tablets.

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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
  • Genera d.d.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 54294
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0190/001
Concerned member states:
  • Austria
  • Belgium
  • 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

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Danish (, TABLETTER 5 MG OG 20 MG)
Published on: 29/06/2023
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."