Veterinary Medicines

FLUDOSOL 200 MG/ML SUSPENSION FOR USE IN DRINKING WATER FOR PIGS AND CHICKENS

Authorised
  • Flubendazole
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Product identification

Medicine name:
FLUDOSOL 200 MG/ML SUSPENSION FOR USE IN DRINKING WATER FOR PIGS AND CHICKENS
Fludosol, 200 mg/ml, suspension för användning i dricksvatten
Active substance:
  • Flubendazole
Target species:
  • Chicken
  • Pig
Route of administration:
  • In drinking water use

Product details

Active substance and strength:
  • Flubendazole
    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
      • Meat and offal
        2
        day
      • Eggs
        0
        day
    • Pig
      • Meat and offal
        4
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP52AC12
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Sweden
Package description:
  • Round bottle of 250 mL
  • Round bottle of 1L with HDPE cap
  • Round bottle of 1 L with LDPE cap
  • Jerrycan of 5 L

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:
  • Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Dopharma B.V.
  • Dopharma France S.A.S.
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 62689
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0449/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 25/03/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 25/03/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 19/06/2024
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