Veterinary Medicines

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

Authorised
  • Methadone hydrochloride
Download as PDF

Product identification

Medicine name:
Insistor 10 mg/ml solution for injection for dogs and cats
Insistor 10 mg/ml Roztwór do wstrzykiwań
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:
  • Poland
Available in:
  • Poland
Package description:
  • Clear glass vial with grey, coated chlorobutyl rubber stopper and aluminium pull off cap or aluminium/plastic flip off cap. Package size 1x 5 ml
  • Clear glass vial with grey, coated chlorobutyl rubber stopper and aluminium pull off cap or aluminium/plastic flip off cap. Package size 5x 10 ml
  • Clear glass vial with grey, coated chlorobutyl rubber stopper and aluminium pull off cap or aluminium/plastic flip off cap. Package size 5 x 5 ml
  • Clear glass vial with grey, coated chlorobutyl rubber stopper and aluminium pull off cap or aluminium/plastic flip off cap. Package size 1x 10 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetviva Richter GmbH
Responsible authority:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3106
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0235/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/10/2024
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/10/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 25/10/2024
Download

Combined File of all Documents

English (PDF)
Published on: 16/05/2025
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."