Veterinary Medicines

Epityl 60mg Flavoured Tablets for Dogs

Authorised
  • Phenobarbital
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Product identification

Medicine name:
Epityl 60mg Flavoured Tablets for Dogs
Epityl 60 mg okusne tablete za pse
Active substance:
  • Phenobarbital
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Phenobarbital
    60.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable 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:
  • Slovenia
Package description:
  • White HDPE containers with a polypropylene child resistant cap containing 500 tablets.
  • White HDPE containers with a polypropylene child resistant cap containing 100 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 1000 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 500 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 100 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 90 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 80 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 70 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 60 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 50 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 40 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 30 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 20 tablets.
  • Blister strips (PVC/Aluminium) containing 10 tablets in cartons of 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:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0788/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0625/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • 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.
Slovenian (PDF)
Published on: 2/04/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 2/04/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 2/04/2024
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