Veterinary Medicine Information website

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

Authorised
  • Alfaxalone
Download as PDF

Product identification

Medicine name:
ALFAXAN 10 mg/ml solution for injection for dogs and cats
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:
  • Valid
Authorised in:
  • Ireland
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 Belgium S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Belgium
Responsible authority:
  • Health Products Regulatory Authority
Authorisation number:
  • VPA10387/103/001
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0590/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • Portugal
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
Download

ie-puar-mr-iev0590001-alfaxan-10-mgml-solution-for-injection-for-dogs-an-en.pdf

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