Veterinary Medicines

Comfortan 10 mg/ml solution for injection for dogs and cats

Authorised
  • Methadone hydrochloride
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Product identification

Medicine name:
Comfortan 10 mg/ml solution for injection for dogs and cats
Comfortan Vet. 10 mg/ml injektionsvæske, opløsning
Active substance:
  • Methadone hydrochloride
Target species:
  • Dog
  • Cat
Route of administration:
  • Intramuscular use
  • Intravenous use
  • Subcutaneous use

Product details

Active substance and strength:
  • Methadone hydrochloride
    10.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AC90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Cardboard box containing 1 vial (uncoloured glass type I, closed teflon-coated chlorobutyl rubber stopper type I, secured with an aluminium cap) filled with 50 ml
  • Cardboard box containing 1 vial (uncoloured glass type I, closed teflon-coated chlorobutyl rubber stopper type I, secured with an aluminium cap) filled with 5 ml
  • Cardboard box containing 1 vial (uncoloured glass type I, closed teflon-coated chlorobutyl rubber stopper type I, secured with an aluminium cap) filled with 30 ml
  • Cardboard box containing 1 vial (uncoloured glass type I, closed teflon-coated chlorobutyl rubber stopper type I, secured with an aluminium cap) filled with 25 ml
  • Cardboard box containing 1 vial (uncoloured glass type I, closed teflon-coated chlorobutyl rubber stopper type I, secured with an aluminium cap) filled with 20 ml
  • Cardboard box containing 1 vial (uncoloured glass type I, closed teflon-coated chlorobutyl rubber stopper type I, secured with an aluminium cap) filled with 10 ml

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:
  • 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:
  • 46793
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0150/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Denmark
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Norway
  • Poland
  • Portugal
  • Slovenia
  • 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.
Danish (, INJEKTIONSVÆSKE, OPLØSNING 10 MG-ML)
Published on: 26/05/2024
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Combined File of all Documents

English (PDF)
Published on: 31/08/2023
Updated on: 4/09/2023
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PuAR Comfortan REG NL 107389 _updated 20230831.pdf

English (PDF)
Published on: 31/08/2023
Updated on: 4/09/2023
Download