Xylasol 20 mg/ml, solution for injection for cattle, horses, dogs and cats
Xylasol 20 mg/ml, solution for injection for cattle, horses, dogs and cats
Authorised
- Xylazine hydrochloride
Product identification
Medicine name:
Xylasol 20 mg/ml, solution for injection for cattle, horses, dogs and cats
Xysol vet. 20 mg/ml injeksjonsvæske, oppløsning til storfe, hest, hund og katt
Active substance:
- Xylazine hydrochloride
Target species:
-
Cattle
-
Horse
-
Dog
-
Cat
Route of administration:
-
Intramuscular use
-
Intravenous use
-
Subcutaneous use
Product details
Active substance and strength:
-
Xylazine hydrochloride23.31milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
Milkno withdrawal periodShould be 0 days
-
Meat and offal1day
-
- Horse
-
Milkno withdrawal periodShould be 0 days
-
Meat and offal1day
-
- Dog
- Cat
-
Intravenous use
- Cattle
-
Milkno withdrawal periodShould be 0 days
-
Meat and offal1day
-
- Horse
-
Milkno withdrawal periodShould be 0 days
-
Meat and offal1day
-
- Dog
- Cat
-
Subcutaneous use
- Cattle
-
Milkno withdrawal periodShould be 0 days
-
Meat and offal1day
-
- Horse
-
Milkno withdrawal periodShould be 0 days
-
Meat and offal1day
-
- Dog
- Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN05CM92
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Norway
Available in:
-
Norway
Package description:
- Cardboard box containing 1 vial (uncoloured glass type II, closed with bromobutyl rubber stopper, secured with aluminium cap) filled with 50 ml
- Cardboard box containing 1 vial (uncoloured glass type II, closed with bromobutyl rubber stopper, secured with aluminium cap) filled with 25 ml
- Cardboard box containing 1 vial (uncoloured glass type II, closed with bromobutyl rubber stopper, secured with aluminium cap) filled with 10 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:
- CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
- Cp-Pharma Handelsgesellschaft mbH
Responsible authority:
- Norwegian Medical Products Agency
Authorisation number:
- 10-8082
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0158/001
Concerned member states:
-
Austria
-
Denmark
-
Finland
-
France
-
Germany
-
Hungary
-
Norway
-
Spain
-
Sweden
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: 21/06/2022
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Norwegian (PDF)
Published on: 17/01/2022
108964 - par.pdf
English (PDF)
Download Published on: 21/06/2022
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