Veterinary Medicines

Phenoleptil 25 mg Tablets for dogs

Authorised
  • Phenobarbital
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Product identification

Medicine name:
Phenoleptil 25 mg Tablets for dogs
Phenoleptil 25 mg tabletter til hund
Active substance:
  • Phenobarbital
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Phenobarbital
    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:
  • QN03AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Norway
Package description:
  • 100 tablets in a cardboard carton containing 10 aluminium/PVC/PE/PVdC blister strips each strip with 10 tablets.
  • 500 tablets in a cardboard carton containing 50 aluminium/PVC/PE/PVdC blister strips each strip with 10 tablets
  • 500 tablets in a cardboard carton containing 50 aluminium/pvc blister strips each strip with 10 tablets.
  • 100 tablets in a cardboard carton containing 10 aluminium/pvc blister strips each strip with 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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
  • Lelypharma B.V.
Responsible authority:
  • Norwegian Medical Products Agency
Authorisation number:
  • 11-8765
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0635/003
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 2/07/2025
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Norwegian (PDF)
Published on: 19/03/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 19/03/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 22/02/2023
Download

Combined File of all Documents

English (PDF)
Published on: 2/07/2025
Download

ie-puar-mr-iev0635003-phenoleptil-25-mg-tablets-for-dogs-en.pdf

English (PDF)
Published on: 2/07/2025
Download
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