Alfaxan Multidose 10 mg/ml solution for injection for dogs, cats and pet rabbits
Alfaxan Multidose 10 mg/ml solution for injection for dogs, cats and pet rabbits
Authorised
- Alfaxalone
Product identification
Medicine name:
Alfaxan Multidose 10 mg/ml solution for injection for dogs, cats and pet rabbits
Alfaxan Multidose 10 mg/ml injekčný roztok pre psy, mačky a domáce králiky
Active substance:
- Alfaxalone
Target species:
-
Dog
-
Cat
-
Rabbit
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:
-
Valid
Authorised in:
-
Slovakia
Available in:
-
Slovakia
Package description:
- Cardboard box with one glass vial of 10 ml with a bromobutyl rubber stopper and aluminium cap.
- Cardboard box with one glass vial of 20 ml with a bromobutyl rubber stopper and aluminium cap.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Zoetis Ceska Republika s.r.o.
Marketing authorisation date:
Manufacturing sites for batch release:
- Zoetis Belgium
Responsible authority:
- Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
- 96/031/DC/18-S
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0592/001
Concerned member states:
-
Austria
-
Belgium
-
Finland
-
France
-
Hungary
-
Italy
-
Netherlands
-
Norway
-
Portugal
-
Slovakia
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
ie-puar-mr-iev0592001-alfaxan-multidose-10-mgml-solution-for-injection-f-en.pdf
English (PDF)
Download Published on: 25/09/2024