Veterinary Medicines Information website

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

Authorised
  • Methadone hydrochloride
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Product identification

Medicine name:
Methadyne 10 mg/ml solution for injection for dogs and cats
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:
  • Sweden
Package description:
  • Presented in a 20 ml amber, Type I glass vial, with Teflon-coated chlorobutyl rubber stopper type 1 secured with a 20 mm aluminium collar with a flip-off cap. 1 vial in a cardboard box.
  • Presented in a 10 ml amber, Type I glass vial, with Teflon-coated chlorobutyl rubber stopper type 1 secured with a 20 mm aluminium collar with a flip-off cap. 1 vial in a cardboard box.
  • Presented in a 5 ml amber, Type I glass vial, with Teflon-coated chlorobutyl rubber stopper type 1 secured with a 20 mm aluminium collar with a flip-off cap. 1 vial in a cardboard box.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Zoetis Animal Health ApS
Marketing authorisation date:
Manufacturing sites for batch release:
  • Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
  • Swedish Medical Products Agency
Authorisation number:
  • 63627
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0783/001
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
Generic of:

Documents

Summary of Product Characteristics

English (PDF)
Published on: 26/08/2024
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Swedish (PDF)
Published on: 15/05/2024
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 10/04/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Swedish (PDF)
Published on: 10/04/2024
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Combined File of all Documents

English (PDF)
Published on: 14/03/2026
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ie-puar-mr-iev0783001-methadyne-10-mgml-solution-for-injection-for-dogs--en.pdf

English (PDF)
Published on: 26/08/2024
Download