Veterinary Medicines

ZOLETIL 100 (50 MG/ML + 50 MG/ML) LYOPHILISATE AND SOLVENT FOR SOLUTION FOR INJECTION FOR DOGS AND CATS

Authorised
  • Tiletamine hydrochloride
  • Water for injection
  • Zolazepam hydrochloride
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Product identification

Medicine name:
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) liofilizat și solvent pentru soluție injectabilă pentru câini și pisici
Active substance:
  • Tiletamine hydrochloride
  • Water for injection
  • Zolazepam hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Tiletamine hydrochloride
    290.86
    milligram(s)
    /
    1.00
    Bottle
  • Water for injection
    5.00
    millilitre(s)
    /
    1.00
    Bottle
  • Zolazepam hydrochloride
    281.88
    milligram(s)
    /
    1.00
    Bottle
Pharmaceutical form:
  • Lyophilisate and solvent for solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
  • Intravenous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01AX99
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • 10 vials of 970 mg lyophilisate and 10 vials of 5 ml solvent
  • 1 vial of 970 mg lyophilisate and 1 vial 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:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 210024
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)

Documents

Summary of Product Characteristics

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Romanian (PDF)
Published on: 5/04/2023
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