Zoletil 50 125 mg - 125 mg Lyofilisaat en oplosmiddel voor oplossing voor injectie
Zoletil 50 125 mg - 125 mg Lyofilisaat en oplosmiddel voor oplossing voor injectie
Authorised
- Tiletamine hydrochloride
- Zolazepam hydrochloride
Product identification
Medicine name:
Zoletil 50 125 mg - 125 mg Lyofilisaat en oplosmiddel voor oplossing voor injectie
Zoletil 50 125 mg - 125 mg Lyophilisat et solvant pour solution injectable
Zoletil 50 125 mg - 125 mg Lyophilisat und Lösungsmittel zur Herstellung einer Injektionslösung
Active substance:
- Tiletamine hydrochloride
- Zolazepam hydrochloride
Target species:
-
Cat
-
Dog
-
Wild animals
Route of administration:
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Tiletamine hydrochloride145.40/milligram(s)1.00Vial
-
Zolazepam hydrochloride140.90/milligram(s)1.00Vial
Pharmaceutical form:
-
Powder 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:
-
Belgium
Package description:
- Zoletil 50 125 mg - 125 mg Lyophilisate and solvent for solution for injection - Box with 10 vials with 675 mg lyophilisate and 10 vials with 5 ml solvent
- Zoletil 50 125 mg - 125 mg Lyophilisate and solvent for solution for injection - Box with 1 vial with 675 mg lyophilisate and 1 vial with 5 ml solvent
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
- Virbac S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V166887
Date of authorisation status change:
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Summary of Product Characteristics
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Labelling
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