Veterinary Medicines

Gallifen 200 mg/ml suspension for use in drinking water for chickens and pheasants

Authorised
  • Fenbendazole
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Product identification

Medicine name:
Gallifen 200 mg/ml suspension for use in drinking water for chickens and pheasants
Gallifen 200 mg/ml εναιώρημα για χορήγηση με πόσιμο νερό για ορνίθια και φασιανούς
Active substance:
  • Fenbendazole
Target species:
  • Chicken
  • Pheasant
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Fenbendazole
    200.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Suspension for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Chicken
      • Eggs
        0
        day
      • Meat and offal
        8
        day
      • Meat and offal
        6
        day
    • Pheasant
      • Eggs
        0
        day
      • Meat and offal
        6
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AC13
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Cyprus
Package description:
  • White rectangular HDPE bottle of 1 litre with vertically see-through bar with an LDPE insert closed with white PP tamper- evident screw cap with a LDPE sealing disk.
  • White HDPE canisters with white HDPE ribbed tamper-evident screw cap of 5 litres.
  • White HDPE canisters with white HDPE ribbed tamper-evident screw cap of 2.5 litres.
  • White cylindrical High Density Polyethylene (HDPE) bottle with white polypropylene (PP) screw tamper-evident closure of 1 litre.
  • White cylindrical High Density Polyethylene (HDPE) bottle with white polypropylene (PP) screw tamper-evident closure of 125 ml.

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:
  • HuVepharma
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biovet J.S.C.
Responsible authority:
  • Ministry Of Agriculture Rural Development And Environment
Authorisation number:
  • CY00663V
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0579/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 11/02/2022
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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Greek (PDF)
Published on: 21/11/2023
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