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 10 mg/ml raztopina za injciranje za pse in mačke
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
Withdrawal period by route of administration:
  • Intramuscular use
    • Dog
    • Cat
  • Intravenous use
    • Dog
    • Cat
  • Subcutaneous use
    • Dog
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AC90
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovenia
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:
  • Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia
Authorisation number:
  • MR/V/0563/001
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.
Slovenian (PDF)
Published on: 29/02/2024
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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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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 29/02/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Slovenian (PDF)
Published on: 29/02/2024
Download

PuAR Comfortan REG NL 107389 _updated 20230831.pdf

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