Recudon 5 mg/ml + 0.25 mg/ml solution for injection for horses and dogs
Recudon 5 mg/ml + 0.25 mg/ml solution for injection for horses and dogs
Authorised
- Levomethadone
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 solution injectable pour chevaux et chiens
Recudon 5 mg/ml + 0,25 mg/ml oplossing voor injectie voor paarden en honden
Recudon 5 mg/ml + 0,25 mg/ml Injektionslösung für Pferde und Hunde
Active substance:
- Levomethadone
Target species:
-
Horse
-
Dog
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Levomethadone4.40milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
- Horse
-
Meat and offal3day
-
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN02AC52
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Cardboard box with 1 clear glass (Type I) vial of 10 ml , 30 ml or 50 ml with a coated bromobutyl rubber stopper and aluminium cap.
- Cardboard box with 1 clear glass (Type I) vial of 10 ml , 30 ml or 50 ml with a coated bromobutyl rubber stopper and aluminium cap.
- Cardboard box with 1 clear glass (Type I) vial of 10 ml , 30 ml or 50 ml with a coated bromobutyl rubber stopper and aluminium cap.
- Cardboard box with 1 clear glass (Type I) vial of 10 ml , 30 ml or 50 ml with a coated bromobutyl rubber stopper and aluminium cap. 5 ml (in a 10 ml sized vial)
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:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V661870
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0384/001-002/DC
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet and Labelling
English (PDF)
Download Published on: 31/08/2023
Labelling
This document does not exist in this language (English). You can find it in another language below.
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
How useful was this page?: