Fenflor 300 mg/ml solution for injection for cattle
Fenflor 300 mg/ml solution for injection for cattle
Authorised
- Florfenicol
Product identification
Medicine name:
Fenflor 300 mg/ml solution for injection for cattle
Fenflor 300 mg/ml solution for injection for cattle
Active substance:
- Florfenicol
Target species:
-
Cattle
Route of administration:
-
Subcutaneous use
-
Intramuscular 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:
-
Subcutaneous use
- Cattle
-
Meat and offal44dayby SC (at 40 mg/kg bodyweight, once)
-
Milkno withdrawal periodNot authorised for use in animals producing milk for human consumption.
-
-
Intramuscular use
- Cattle
-
Meat and offal30dayby IM (at 20 mg/kg bodyweight, twice)
-
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:
-
Ireland
Package description:
- (ID3): 1 unspecified outer container with 1 Vial (Glass) with 250 millilitre(s) (250 millilitre(s))
- (ID2): 1 unspecified outer container with 1 Vial (Glass) with 100 millilitre(s) (100 millilitre(s))
- (ID1): 1 unspecified outer container with 1 Vial (Glass) with 50 millilitre(s) (50 millilitre(s))
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:
- Krka d.d. Novo Mesto
Responsible authority:
- Health Products Regulatory Authority
Authorisation number:
- VPA10774/010/001
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0195/002
Concerned member states:
-
Austria
-
Belgium
-
Ireland
-
Portugal
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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