ALFAXAN 10 mg/ml solution for injection for dogs and cats
ALFAXAN 10 mg/ml solution for injection for dogs and cats
Authorised
- Alfaxalone
Product identification
Medicine name:
ALFAXAN 10 mg/ml solution for injection for dogs and cats
Alfaxan 10 mg/ml injektioneste, liuos
Active substance:
- Alfaxalone
Target species:
-
Dog
-
Cat
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Alfaxalone10.00milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
- Dog
- Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN01AX05
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Finland
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 Animal Health ApS
Marketing authorisation date:
Manufacturing sites for batch release:
- Jurox (Ireland) Limited
- Zoetis Belgium
Responsible authority:
- Finnish Medicines Agency
Authorisation number:
- 32436
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 3/05/2024
Finnish (PDF)
Published on: 18/06/2024
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Finnish (PDF)
Published on: 18/06/2024
How useful was this page?: