Veterinary Medicines

Fentadon 50 microgram/ml, solution for injection for dogs

Authorised
  • Fentanyl citrate
Download as PDF

Product identification

Medicine name:
Fentadon 50 microgram/ml, solution for injection for dogs
Fentadon 50 mikrogramów/ml, roztwór do wstrzykiwań dla psów
Active substance:
  • Fentanyl citrate
Target species:
  • Dog
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Fentanyl citrate
    78.50
    microgram(s)
    /
    1.00
    millilitre(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:
  • Poland
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:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 2257
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)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 4/02/2022
Download

Combined File of all Documents

English (PDF)
Published on: 20/06/2022
Download

108332 PAR.pdf

English (PDF)
Published on: 20/06/2022
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."