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 solução injetável para bovinos
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:
-
Portugal
Package description:
- (ID3) 250 millilitre(s): Box (board) with 1 Vial (brown glass) with 250 millilitre(s), closed with Stopfen (bromobutyl rubber) and Cap`` (aluminium)
- (ID2) 100 millilitre(s): Box (board) with 1 Vial (brown glass) with 100 millilitre(s), closed with Stopfen (bromobutyl rubber) and Cap`` (aluminium)
- (ID1) 50 millilitre(s): Box (board) with 1 Vial (brown glass) with 50 millilitre(s), closed with Stopfen (bromobutyl rubber) and Cap`` (aluminium)
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 tovarna zdravil d.d. Novo mesto
Responsible authority:
- Directorate General For Food And Veterinary
Authorisation number:
- 152/01/09RFVPT
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
