Butazocare flavour 1g granules in sachet for horses and ponies
Butazocare flavour 1g granules in sachet for horses and ponies
Authorised
- Phenylbutazone
Product identification
Medicine name:
Butazocare flavour 1g granules in sachet for horses and ponies
Butazocare flavour 1g Granulat im Beutel für Pferde und Ponys
Active substance:
- Phenylbutazone
Target species:
-
Horse (non food-producing)
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Phenylbutazone1000.00/milligram(s)2.00gram(s)
Pharmaceutical form:
-
Granules in sachet
Withdrawal period by route of administration:
-
Oral use
-
Horse (non food-producing)
-
Meat and offalno withdrawal periodNot to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.
-
Milkno withdrawal periodNot to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Austria
Package description:
- (ID2) 200 gram(s): unspecified outer container with 100 Bag (paper; polyethylene; aluminium; polyethylene) each with 2 gram(s)
- (ID1) 64 gram(s): unspecified outer container with 32 Bag (paper; polyethylene; aluminium; polyethylene) each with 2 gram(s)
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Ecuphar
Marketing authorisation date:
Manufacturing sites for batch release:
- Labo Smeets
Responsible authority:
- Austrian Agency For Health And Food Safety
Authorisation number:
- 838820
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0332/001
Concerned member states:
-
Austria
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
This document does not exist in this language (English). You can find it
in another language below.
German (PDF)
Published on: 16/04/2019
Updated on: 22/01/2025
Summary of Product Characteristics
English (PDF)
Download Published on: 7/01/2026
German (PDF)
Published on: 16/04/2019
Updated on: 22/01/2025
Labelling
This document does not exist in this language (English). You can find it
in another language below.
German (PDF)
Published on: 16/04/2019
Updated on: 22/01/2025
