Flordofen 300 mg/ml solution for injection for cattle and pigs
Flordofen 300 mg/ml solution for injection for cattle and pigs
Authorised
- Florfenicol
Product identification
Medicine name:
Flordofen 300 mg/ml solution for injection for cattle and pigs
Active substance:
- Florfenicol
Target species:
-
Pig (for fattening)
-
Cattle
Route of administration:
-
Intramuscular use
-
Subcutaneous use
Product details
Active substance and strength:
-
Florfenicol300.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
-
Pig (for fattening)
-
Meat and offal18day
-
-
Cattle
-
Meat and offal30dayMilk: Not authorised for use in animals producing milk for human consumption, including during the dry period.
-
-
-
Subcutaneous use
-
Cattle
-
Meat and offal44dayMilk: Not authorised for use in animals producing milk for human consumption, including during the dry period.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01BA90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Brown-coloured type II glass vial of 250 ml, closed by a type I bromobutyl stopper and sealed by an aluminium cap with centre hole.
- Colourless type II glass vial of 100 ml, closed by a type I bromobutyl stopper and sealed by an aluminium cap with centre hole.
- Colourless type II glass vial of 50 ml, closed by a type I bromobutyl stopper and sealed by an aluminium cap with centre hole.
- Polypropylene vial of 250 ml, closed with bromobutyl stopper secured with flip off aluminium collar.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Dopharma Research B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Dopharma B.V.
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:
-
Portugal
Procedure number:
- PT/V/0112/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Czechia
-
Denmark
-
Estonia
-
France
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Poland
-
Romania
-
Slovakia
-
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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Labelling
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Combined File of all Documents
English (PDF)
Download Published on: 28/07/2025
