Xylexx 20 mg/ml solution for injection for cattle, horses, dogs and cats
Xylexx 20 mg/ml solution for injection for cattle, horses, dogs and cats
Authorised
- Xylazine
Product identification
Medicine name:
Xylexx 20 mg/ml Injektionslösung für Rinder, Pferde, Hunde und Katzen
Xylexx 20 mg/ml solution for injection for cattle, horses, dogs and cats
Active substance:
- Xylazine
Target species:
-
Cat
-
Cattle
-
Dog
-
Horse
Route of administration:
-
Subcutaneous use
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Xylazine20.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Subcutaneous use
- Cat
-
Intramuscular use
- Cattle
-
Meat and offal1day1 day
-
- Dog
- Cat
-
Intravenous use
- Horse
-
Meat and offal1day1 day
-
- Cattle
-
Meat and offal1day1 day
-
Milkno withdrawal period0 hours
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05CM92
Legal status of supply:
-
Medicinal product on medical prescription for renewable delivery
Authorisation status:
-
Valid
Authorised in:
-
Austria
Available in:
-
Austria
Package description:
- Clear type II glass vials containing 30 ml product, closed with a bromobutyl rubber stopper and aluminium cap in a polystyrene box.
- Clear type II glass vials containing 30 ml product, closed with a bromobutyl rubber stopper and aluminium cap in a cardboard box
- Clear type II glass vials containing 30 ml product, closed with a bromobutyl rubber stopper and aluminium cap in a cardboard or polystyrene box
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:
- Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Alfasan Nederland B.V.
Responsible authority:
- Austrian Agency For Health And Food Safety
Authorisation number:
- 841474
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0366/001/DC
Concerned member states:
-
Austria
-
Belgium
-
Bulgaria
-
Croatia
-
Cyprus
-
Czechia
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
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
Combined File of all Documents
English (PDF)
Download Published on: 28/11/2022
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 11/05/2023
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 15/11/2022
Labelling
This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 11/05/2023
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