Veterinary Medicines

ALFAXAN 10 mg/ml solution for injection for dogs and cats

Not authorised
  • Alfaxalone
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Product identification

Medicine name:
ALFAXAN 10 mg/ml solution for injection for dogs and cats
Alfaxan
Active substance:
  • Alfaxalone
Target species:
  • Dog
  • Cat
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Alfaxalone
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN01AX05
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Germany
Package description:
  • Cardboard box with one glass vial of 10 ml with a bromobutyl rubber stopper and aluminium cap.

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:
  • Zoetis Deutschland GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • 401104.00.00
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0590/001

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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German (PDF)
Published on: 19/12/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 19/12/2024
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ie-puar-mr-iev0590001-alfaxan-10-mgml-solution-for-injection-for-dogs-an-en.pdf

English (PDF)
Published on: 1/12/2024
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