Fluboral 200 mg/ml, suspension for use in drinking water for pigs and chickens
Fluboral 200 mg/ml, suspension for use in drinking water for pigs and chickens
Authorised
- Flubendazole
Product identification
Medicine name:
Fluboral 200 mg/ml, suspension for use in drinking water for pigs and chickens
Fluboral 200 mg/ml Suspension pour administration dans l’eau de boisson
Fluboral 200 mg/ml Suspensie voor gebruik in drinkwater
Fluboral 200 mg/ml Suspension zum Eingeben über das Trinkwasser
Active substance:
- Flubendazole
Target species:
-
Chicken
-
Pig
Route of administration:
-
In drinking water use
Product details
Active substance and strength:
-
Flubendazole200.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Suspension for use in drinking water
Withdrawal period by route of administration:
-
In drinking water use
- Chicken
-
Eggs0day
-
Meat and offal2day
-
- Pig
-
Meat and offal4day1 mg / kg for 5 days.
-
Meat and offal5day2.5 mg / kg for 2 days.
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP52AC12
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Semi-transparent high density polyethylene bottle of 3 litre closed with white high density polyethylene screw-cap containing low density polyethylene sealing element.
- Semi-transparent high density polyethylene bottle of 1 litre closed with white high density polyethylene screw-cap containing low density polyethylene sealing element.
- Semi-transparent high density polyethylene bottle of 250 ml closed with white high density polyethylene screw-cap containing low density polyethylene sealing element.
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:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Genera d.d.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
This information is not available for this product.
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0664/001
Concerned member states:
-
Austria
-
Belgium
-
Croatia
-
Denmark
-
France
-
Germany
-
Italy
-
Netherlands
-
Poland
-
Portugal
-
Slovenia
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Package Leaflet
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