Veterinary Medicines

Synthadon 5 mg/ml solution for injection for dogs and cats

Authorised
  • Methadone hydrochloride
Download as PDF

Product identification

Medicine name:
Synthadon 5 mg/ml solution for injection for dogs and cats
Synthadon 5 mg/ml Injektionslösung für Katzen und Hunde
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
    5.00
    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:
  • QN02AC52
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:
  • Cardboard box containing 1 vial of 50 ml.
  • Cardboard box containing 1 vial of 5 ml.
  • Clear colourless type I glass bottle with a teflon coated bromobutyl rubber 20 mm stopper and aluminium 20 mm cap.
  • Cardboard box containing 1 vial of 30 ml.
  • Cardboard box containing 1 vial of 25 ml.
  • Cardboard box containing 1 vial of 20 ml.
  • Cardboard box containing 1 vial of 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:
  • Le Vet. Beheer B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Produlab Pharma B.V.
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 835670
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0183/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Greece
  • Hungary
  • Iceland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 10/07/2019
Updated on: 19/04/2022
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 10/07/2019
Updated on: 19/04/2022
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 10/07/2019
Updated on: 19/04/2022
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."