ALFAXAN 10 mg/ml solution for injection for dogs and cats
ALFAXAN 10 mg/ml solution for injection for dogs and cats
Not authorised
- Alfaxalone
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:
-
Alfaxalone10.00/milligram(s)1.00millilitre(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:
-
Belgium
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
Marketing authorisation date:
Manufacturing sites for batch release:
- Zoetis Belgium
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V317204
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0590/001
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Labelling
This document does not exist in this language (English). You can find it in another language below.
ie-puar-mr-iev0590001-alfaxan-10-mgml-solution-for-injection-for-dogs-an-en.pdf
English (PDF)
Download Published on: 1/12/2024