Veterinary Medicines

Fentadon 50 microgram/ml, solution for injection for dogs

Authorised
  • Fentanyl citrate
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Product identification

Medicine name:
Fentadon 50 microgram/ml, solution for injection for dogs
Fentadon 50 µg/ml Oplossing voor injectie
Fentadon 50 µg/ml Solution injectable
Fentadon 50 µg/ml Injektionslösung
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:
  • Belgium
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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Eurovet Animal Health B.V.
Responsible authority:
  • FAMHP
Authorisation number:
  • BE-V416026
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)

Documents

Combined File of all Documents

English (PDF)
Published on: 20/06/2022
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Summary of Product Characteristics

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Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 22/03/2022
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French (PDF)
Published on: 22/03/2022
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German (PDF)
Published on: 22/03/2022
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108332 PAR.pdf

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