FLORON 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
FLORON 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Authorised
- Florfenicol
Product identification
Medicine name:
FLORON 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Active substance:
- Florfenicol
Target species:
-
Cattle
-
Pig
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
-
Cattle
-
Meat and offal30daydosage 20 mg/kg bodyweight, twice
-
Milkno withdrawal periodNot authorised for use in animals producing milk for human consumption.
-
-
Pig
-
Meat and offal18day
-
-
-
Subcutaneous use
-
Cattle
-
Meat and offal44daydosage 40 mg/kg bodyweight, once
-
Milkno withdrawal periodNot authorised for use in animals producing milk for human consumption.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01BA90
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- Cardboard box containing one Type I amber glass bottle of 50 ml
- Cardboard box containing one Type I amber glass bottle of 250 ml
- Cardboard box containing one Type I amber glass bottle of 100 ml
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:
- KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
- TAD Pharma GmbH
- KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V470311
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0280/001
Concerned member states:
-
Belgium
-
Germany
-
Italy
-
Netherlands
-
Portugal
-
Spain
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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