Veterinary Medicines

Zoletil 100, (50 mg/ml+50 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:
Золетил 100, (50 mg/ml+50 mg/ml) лиофилизат и разтворител за инжекционен разтвор за кучета и котки
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:
  • Cat
  • Dog
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Tiletamine hydrochloride
    250.00
    milligram(s)
    /
    1.00
    Vial
  • Zolazepam hydrochloride
    250.00
    milligram(s)
    /
    1.00
    Vial
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:
  • Bulgaria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
  • Virbac
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2045
Date of authorisation status change:

Documents

Summary of Product Characteristics

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Bulgarian (PDF)
Published on: 29/12/2025
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Labelling

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Bulgarian (PDF)
Published on: 29/12/2025
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Package Leaflet

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Bulgarian (PDF)
Published on: 29/12/2025
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