Fenflor 300 mg/ml solution for injection for pigs
Fenflor 300 mg/ml solution for injection for pigs
Authorised
- Florfenicol
Product identification
Medicine name:
Fenflor 300 mg/ml solution for injection for pigs
Fenflor 300 mg/ml Oplossing voor injectie
Fenflor 300 mg/ml Solution injectable
Fenflor 300 mg/ml Injektionslösung
Active substance:
- Florfenicol
Target species:
-
Pig
Route of administration:
-
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:
-
Intramuscular use
-
Pig
-
Meat and offal18day
-
-
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:
- (ID3) 250 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 250 millilitre(s), closed with Cap and Stopper (Aluminium, bromobutyl rubber`)
- (ID2) 100 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 100 millilitre(s), closed with Cap and Stopper (Aluminium, bromobutyl rubber`)
- (ID1) 50 millilitre(s): Box (Cardboard) with 1 Vial (Glass) with 50 millilitre(s), closed with Cap and Stopper (Aluminium, bromobutyl rubber`)
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:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V327293
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0195/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Ireland
-
Portugal
-
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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Combined File of all Documents
English (PDF)
Download Published on: 17/04/2024
Labelling
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