Veterinary Medicines

AMPHEN 200 MG/ML SUSPENSION FOR USE IN DRINKING WATER FOR PIGS

Authorised
  • Florfenicol
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Product identification

Medicine name:
AMPHEN 200 MG/ML SUSPENSION FOR USE IN DRINKING WATER FOR PIGS
Amphen 200 mg/ml suspension til anvendelse i drikkevand
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
    millilitre(s)
Pharmaceutical form:
  • Suspension 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:
  • Denmark
Package description:
  • White rectangular HPDE bottle of 1 litre (1000 mL)

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • HuVepharma
Marketing authorisation date:
Manufacturing sites for batch release:
  • Biovet AD
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 68373
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0460/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

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Danish (PDF)
Published on: 28/05/2024
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