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 + 0,25 mg)/1 ml Roztwór do wstrzykiwań
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:
  • Poland
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:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3308
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)
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