Veterinary Medicines

Amphen, 200 mg/g Granuals for Use in Drinking Water for Pigs

Authorised
  • Florfenicol
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Product identification

Medicine name:
Amphen, 200 mg/g Granuals for Use in Drinking Water for Pigs
Amphen, 200 mg/g granulaat voor gebruik in drinkwater voor varkens.
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:
  • Netherlands
Package description:
  • Polyester/aluminium/polythene bags containing 5 kg of granules.
  • Polyester/aluminium/polythene bags containing 1 kg of granules.
  • Polyester/aluminium/polythene bags containing 0.5 kg of granules.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • HuVepharma
Marketing authorisation date:
Manufacturing sites for batch release:
  • Labo Smeets
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 111741
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0306/001
Concerned member states:
  • Hungary
  • Italy

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 19/01/2022
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