Veterinary Medicines

HEDYLON 5 mg TABLETS FOR DOGS AND CATS

Authorised
  • Prednisolone
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Product identification

Medicine name:
HEDYLON 5 mg TABLETS FOR DOGS AND CATS
Prednicure 5 mg Tablet
Prednicure 5 mg Comprimé
Prednicure 5 mg Tablette
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:
  • Belgium
Available in:
  • Belgium
Package description:
  • cardboard box containing 250 tablets (25 blister)
  • cardboard box containing 100 tablets (10 blister)
  • cardboard box containing 50 tablets (5 blister)
  • cardboard box containing 30 tablets (3 blister)
  • cardboard box containing 10 tablets (1 blister)

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:
  • Livisto Int'l S.L.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
  • Animedica GmbH
  • Animedica Herstellungs GmbH
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V546755
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0292/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Sweden

Documents

Summary of Product Characteristics

English (PDF)
Published on: 22/12/2023
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Dutch (PDF)
Published on: 19/01/2023
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French (PDF)
Published on: 19/01/2023
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 19/01/2023
Download
French (PDF)
Published on: 19/01/2023
Download
German (PDF)
Published on: 19/01/2023
Download

eu-PUAR-esv0292001-dcp-hedylon--5-mg-tablets-for-dogs-and-cats-en.pdf

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