Fentadon 50 microgram/ml, solution for injection for dogs
Fentadon 50 microgram/ml, solution for injection for dogs
Authorised
- Fentanyl citrate
Product identification
Medicine name:
Fentadon 50 microgram/ml, solution for injection for dogs
Fentadon Vet. 50 mikrogram/ml injektionsvæske, opløsning
Active substance:
- Fentanyl citrate
Target species:
-
Dog
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Fentanyl citrate78.50microgram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN02AB03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Denmark
Package description:
- Vial of uncoloured glass type I, filled with 10 ml. Teflon-coated chlorobutyl rubber stoppers type I secured with aluminium caps.
- Vial of uncoloured glass type I, filled with 100 ml. Teflon-coated chlorobutyl rubber stoppers type I secured with aluminium caps.
- Vial of uncoloured glass type I, filled with 50 ml. Teflon-coated chlorobutyl rubber stoppers type I secured with aluminium caps.
- Vial of uncoloured glass type I, filled with 5 ml. Teflon-coated chlorobutyl rubber stoppers type I secured with aluminium caps.
- Vial of uncoloured glass type I, filled with 30 ml. Teflon-coated chlorobutyl rubber stoppers type I secured with aluminium caps.
- Vial of uncoloured glass type I, filled with 25 ml. Teflon-coated chlorobutyl rubber stoppers type I secured with aluminium caps.
- Vial of uncoloured glass type I, filled with 20 ml. Teflon-coated chlorobutyl rubber stoppers type I secured with aluminium caps.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Well-established use application (Article 13a of Directive No 2001/82/EC)
Marketing authorisation holder:
- Eurovet Animal Health B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Eurovet Animal Health B.V.
Responsible authority:
- Danish Medicines Agency
Authorisation number:
- 47538
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0155/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
France
-
Germany
-
Italy
-
Luxembourg
-
Norway
-
Poland
-
Portugal
-
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
This document does not exist in this language (English). You can find it in another language below.
Danish (, INJEKTIONSVÆSKE, OPLØSNING 50 MIKROGRAM-ML)
Published on: 29/06/2023
Combined File of all Documents
English (PDF)
Download Published on: 20/06/2022
108332 PAR.pdf
English (PDF)
Download Published on: 20/06/2022
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