Veterinary Medicine Information website

Amphen 200 mg/g granules for use in drinking water for pigs

Authorised
  • Florfenicol
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Product identification

Medicine name:
Amphen 200 mg/g granules for use in drinking water for pigs
Active substance:
  • Florfenicol
Target species:
  • Pig
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Florfenicol
    200.00
    milligram(s)
    /
    1.00
    gram(s)
Pharmaceutical form:
  • Granules for use in drinking water
Withdrawal period by route of administration:
  • In drinking water use
    • Pig
      • Meat and offal
        20
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QJ01BA90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Italy
Package description:
  • Resealable block bottom zipped bags made of polyethylene /aluminium/polyethylene terephthalate laminate containing 1 kg granules.
  • Resealable block bottom zipped bags made of polyethylene /aluminium/polyethylene terephthalate laminate containing 0.5 kg of granules.

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:
  • Labo Smeets
Responsible authority:
  • Ministry Of Health
Authorisation number:
  • 105272
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0264/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

English (PDF)
Published on: 13/11/2024
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Italian (PDF)
Published on: 19/09/2023
Updated on: 21/09/2023
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