Veterinary Medicines

HEDYLON 25 mg TABLETS FOR DOGS

Authorised
  • Prednisolone
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Product identification

Medicine name:
HEDYLON 25 mg TABLETS FOR DOGS
Hedylon 25 mg tablete za pse
Active substance:
  • Prednisolone
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Prednisolone
    25.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QH02AB06
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
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:
  • Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Industrial Veterinaria S.A.
  • aniMedica GmbH
  • aniMedica Herstellungs GmbH
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • DC/V/0650/002
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0292/002
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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Slovenian (PDF)
Published on: 5/09/2024
Updated on: 19/09/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 5/09/2024
Updated on: 19/09/2024
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 5/09/2024
Updated on: 19/09/2024
Download

eu-PUAR-esv0292002-dcp-hedylon-25-mg-tablets-for-dogs-en.pdf

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