Zoletil 100 (50 mg/ml+50 mg/ml) Lyophilisate and Solvent for Solution for Injection for Dogs and Cats
Zoletil 100 (50 mg/ml+50 mg/ml) Lyophilisate and Solvent for Solution for Injection for Dogs and Cats
Authorised
- Tiletamine hydrochloride
- Zolazepam hydrochloride
Product identification
Medicine name:
Zoletil 100 (50 mg/ml+50 mg/ml) Lyophilisate and Solvent for Solution for Injection for Dogs and Cats
Active substance:
- Tiletamine hydrochloride
- Zolazepam hydrochloride
Target species:
-
Dog
-
Cat
Route of administration:
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Tiletamine hydrochloride290.86/milligram(s)1.00Bottle
-
Zolazepam hydrochloride281.88/milligram(s)1.00Bottle
Pharmaceutical form:
-
Lyophilisate and solvent for solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN01AX99
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
United Kingdom (Northern Ireland)
Available in:
-
United Kingdom (Northern Ireland)
Package description:
- 1 vial of 970 mg lyophilisate and 1 vial of 5 ml solvent
- 10 vials of 970 mg lyophilisate and 10 vials of 5 ml solvent
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:
- Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
- Virbac
Responsible authority:
- The Veterinary Medicines Directorate
Authorisation number:
- Vm 05653/3048
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0283/002
Concerned member states:
-
Austria
-
Finland
-
Germany
-
Ireland
-
Malta
-
Netherlands
-
Poland
-
Romania
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
