Veterinary Medicines

ZOLETIL 50 (25 MG/ML + 25 MG/ML) LYOPHILISATE AND SOLVENT FOR SOLUTION FOR INJECTION FOR DOGS AND CATS

Authorised
  • Tiletamine hydrochloride
  • Zolazepam hydrochloride
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Product identification

Medicine name:
ZOLETIL 50 (25 MG/ML + 25 MG/ML) LYOPHILISATE AND SOLVENT FOR SOLUTION FOR INJECTION FOR DOGS AND CATS
Zoletil 50 (25 mg/ml+25 mg/ml) lyofilisaat en oplosvloeistof voor oplossing voor injectie voor honden en katten
Active substance:
  • Tiletamine hydrochloride
  • Zolazepam hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Tiletamine hydrochloride
    145.43
    milligram(s)
    /
    1.00
    Bottle
  • Zolazepam hydrochloride
    140.94
    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:
  • Netherlands
Available in:
  • Netherlands
Package description:
  • 1 vial of 675 mg lyophilisate and 1 vial of 5 ml solvent
  • 10 vials of 675 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:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 115911
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0283/001
Concerned member states:
  • Finland
  • Ireland
  • Netherlands
  • Poland
  • Sweden

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 26/04/2022
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