Xylasol 100 mg/ml, solution for injection for cattle and horses
Xylasol 100 mg/ml, solution for injection for cattle and horses
Authorised
- Xylazine hydrochloride
Product identification
Medicine name:
Xylasol 100 mg/ml, solution for injection for cattle and horses
Active substance:
- Xylazine hydrochloride
Target species:
-
Cattle
-
Horse
-
Dog
-
Cat
Route of administration:
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Xylazine hydrochloride116.55milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
-
Milk0hour
-
Meat and offal1day
-
- Horse
-
Milk0hour
-
Meat and offal1day
-
- Dog
- Cat
-
Intravenous use
- Cattle
-
Milk0hour
-
Meat and offal1day
-
- Horse
-
Milk0hour
-
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:
-
Netherlands
Package description:
- 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
- Cardboard box containing 1 vial (uncoloured glass type II, closed with bromobutyl rubber stopper, secured with aluminium cap) filled with 50 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application (Article 13(3) 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:
- Medicines Evaluation Board
Authorisation number:
- REG NL 108965
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0158/002
Concerned member states:
-
Germany
-
Hungary
-
Spain
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
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