Veterinary Medicines

Recudon 5 mg/ml + 0.25 mg/ml solution for injection for horses and dogs

Authorised
  • Levomethadone hydrochloride
  • Fenpipramide hydrochloride
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Product identification

Medicine name:
Recudon 5 mg/ml + 0.25 mg/ml solution for injection for horses and dogs
Recudon 5 mg/ml + 0.25 mg/ml soluție injectabilă pentru cai și câini
Active substance:
  • Levomethadone hydrochloride
  • Fenpipramide hydrochloride
Target species:
  • Horse
  • Dog
Route of administration:
  • Intravenous use

Product details

Active substance and strength:
  • Levomethadone hydrochloride
    5.00
    milligram(s)
    /
    1.00
    millilitre(s)
  • Fenpipramide hydrochloride
    0.25
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intravenous use
    • Horse
      • Meat and offal
        3
        day
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AC52
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
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 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:
  • Hybrid application – change in strength (Article 19(1)(a) 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:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 230145
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0384/002
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Romanian (PDF)
Published on: 17/12/2025
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Summary of Product Characteristics

English (PDF)
Published on: 31/08/2023
Updated on: 4/09/2023
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Package Leaflet and Labelling

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