SELECTAN 300 mg/ml solution for injection for cattle and swine
SELECTAN 300 mg/ml solution for injection for cattle and swine
Authorised
- Florfenicol
Product identification
Medicine name:
SELECTAN 300 mg/ml solution for injection for cattle and swine
Selectan 300 mg/ml Oplossing voor injectie
Selectan 300 mg/ml Solution injectable
Selectan 300 mg/ml Injektionslösung
Active substance:
- Florfenicol
Target species:
-
Cattle
-
Pig
Route of administration:
-
Intramuscular use
Product details
Active substance and strength:
-
Florfenicol300.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
Meat and offal30day
-
- 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:
- The product is bottled in 50 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.One bottle of 50 ml is available in a cardboard box.
- The product is bottled in 100 ml colourless Type II glass bottle or 100 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.One bottle of 100 ml is available in a cardboard box.
- The product is bottled in 250 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.One bottle of 250 ml is available in a cardboard box.
- The product is bottled in 100 ml colourless Type II glass bottle or 100 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.Clinical pack size:10 x 100 ml
- The product is bottled in 250 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.Clinical pack size:10 x 250 ml.
- The product is bottled in 100 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.Clinical pack size: 12 x 100 ml.
- The product is bottled in 250 ml plastic bottle, closed with Type I polymeric elastomer stopper with aluminium cap.Clinical pack size: 12 x 250 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:
- Laboratorios Hipra S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Laboratorios Hipra S.A.
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:
-
Ireland
Procedure number:
- IE/V/0189/001
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Romania
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
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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