Torphasol 10 mg/ml solution for injection for horses
Torphasol 10 mg/ml solution for injection for horses
Authorised
- Butorphanol tartrate
Product identification
Medicine name:
Torphasol 10 mg/ml solution for injection for horses
Active substance:
- Butorphanol tartrate
Target species:
-
Horse
Route of administration:
-
Intravenous use
Product details
Active substance and strength:
-
Butorphanol tartrate14.70/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intravenous use
-
Horse
-
Meat and offal0day
-
Milk0day
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN02AF01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Available in:
-
Belgium
Package description:
- Cardboard box with 1 clear glass vial (type I) of 20 ml with a grey butyl rubber stopper and an aluminium cap.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- aniMedica GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- aniMedica GmbH
- Industrial Veterinaria S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V372547
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0246/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Estonia
-
Finland
-
France
-
Germany
-
Hungary
-
Iceland
-
Italy
-
Latvia
-
Lithuania
-
Luxembourg
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Spain
-
Sweden
-
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.
Combined File of all Documents
English (PDF)
Download Published on: 24/08/2025
Labelling
This document does not exist in this language (English). You can find it in another language below.