Veterinary Medicines

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

Authorised
  • Levomethadone hydrochloride
  • Fenpipramide hydrochloride
Download as PDF

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 oldatos injekció lovak és kutyák részére
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
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN02AC52
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Hungary
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:
  • Directorate Of Veterinary Medicinal Products
Authorisation number:
  • 4384/x/23 NÉBIH ÁTI
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)
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."