Veterinary Medicines

Recudon 2.5 mg/ml + 0.125 mg/ml solution for injection for horses and dogs

Authorised
  • Levomethadone
Download as PDF

Product identification

Medicine name:
Recudon 2.5 mg/ml + 0.125 mg/ml solution for injection for horses and dogs
Recudon 2,5 mg/ml + 0,125 mg/ml Injektionslösung für Pferde und Hunde
Active substance:
  • Levomethadone
Target species:
  • Dog
  • Horse
Route of administration:
  • Intravenous use
  • Intramuscular use

Product details

Active substance and strength:
  • Levomethadone
    2.20
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Dog
    • Horse
      • Meat and offal
        3
        day
  • Intramuscular use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AC52
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Germany
Package description:
  • Cardboard box with 1 clear glass (Type I) vial of 50 ml with a coated bromobutyl rubber stopper and aluminium cap.
  • Cardboard box with 1 clear glass (Type I) vial of 30 ml with a coated bromobutyl rubber stopper and aluminium cap.
  • Cardboard box with 1 clear glass (Type I) vial of 10 ml with a coated bromobutyl rubber stopper and aluminium cap.
  • Cardboard box with 1 clear glass (Type I) vial of 10 ml (5 ml in a 10 ml sized vial) with a coated bromobutyl rubber stopper and aluminium cap.

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Alfasan Nederland B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfasan Nederland B.V.
Responsible authority:
  • Federal Office Of Consumer Protection And Food Safety
Authorisation number:
  • V7009070.00.00
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0384/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)
This information is not available for this product.

Documents

Summary of Product Characteristics

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

Package Leaflet and Labelling

English (PDF)
Published on: 31/08/2023
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."