Veterinary Medicines

Phenoleptil 50 mg tablets for dogs

Authorised
  • Phenobarbital
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Product identification

Medicine name:
Phenoleptil 50 mg tablets for dogs
Phenoleptil 50 mg comprimidos para cães
Active substance:
  • Phenobarbital
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Phenobarbital
    50.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN03AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Portugal
Package description:
  • Aluminium/PVC/PE/PVdC strips with 10 tablets packed in cardboard boxes with 5 strips.
  • Aluminium/PVC/PE/PVdC strips with 10 tablets packed in cardboard boxes with 10 strips.
  • Aluminium/PVC/PE/PVdC strips with 10 tablets packed in cardboard boxes with 25 strips.
  • Aluminium/PVC/PE/PVdC strips with 10 tablets packed in cardboard boxes with 50 strips.
  • Aluminium/PVC/PE/PVdC strips with 10 tablets packed in cardboard boxes with 100 strips.
  • Aluminum/PVC strips with 10 tablets packed in cardboard boxes with 100 strips.
  • Aluminum/PVC strips with 10 tablets packed in cardboard boxes with 50 strips.
  • Aluminum/PVC strips with 10 tablets packed in cardboard boxes with 25 strips.
  • Aluminum/PVC strips with 10 tablets packed in cardboard boxes with 10 strips.
  • Aluminum/PVC strips with 10 tablets packed in cardboard boxes with 5 strips.

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:
  • Lelypharma B.V.
  • Genera d.d.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 332/02/11DFVPT
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0635/002
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/07/2025
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Combined File of all Documents

English (PDF)
Published on: 6/07/2025
Download
Portuguese (PDF)
Published on: 5/09/2025
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