Veterinary Medicines

Zoletil 50 125 mg - 125 mg Lyofilisaat en oplosmiddel voor oplossing voor injectie

Authorised
  • Tiletamine hydrochloride
  • Zolazepam hydrochloride
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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 hydrochloride
    145.40
    milligram(s)
    /
    1.00
    Vial
  • Zolazepam hydrochloride
    140.90
    milligram(s)
    /
    1.00
    Vial
Pharmaceutical form:
  • Powder and solvent for solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cat
    • Dog
    • Wild animals
  • Intravenous use
    • Cat
    • Dog
    • Wild animals
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
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V166887
Date of authorisation status change:

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 23/03/2023
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French (PDF)
Published on: 23/03/2023
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German (PDF)
Published on: 23/03/2023
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Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 23/03/2023
Download
French (PDF)
Published on: 23/03/2023
Download
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