Product identification
Medicine name:
Halofusol 0.5 mg/ml oral solution for calves
Halofusol, 0,5 mg/ml suukaudne lahus vasikatele
Active substance:
- Halofuginone lactate
Target species:
-
Cattle (newborn calf)
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Halofuginone lactate0.61/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Oral solution
Withdrawal period by route of administration:
-
Oral use
- Cattle (newborn calf)
-
Meat and offal13day
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP51BX01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Package description:
- bottle of 1000 ml
- bottle of 500 ml
- bottle of 250 ml
- box containing 1 bottle of 1000 ml with a 4 ml metering pump
- box containing 1 bottle of 1000 ml
- box containing 1 bottle of 500 ml with a 4 ml metering pump
- box containing 1 bottle of 500 ml
- box containing 1 bottle of 250 ml with a 4 ml metering pump
- box containing 1 bottle of 250 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Generic application (Article 13(1) of Directive No 2001/82/EC)
Manufacturing sites for batch release:
- Laboratorios Karizoo S.A.
Authorisation number:
- 2234
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0351/001
Concerned member states:
-
Belgium
-
Cyprus
-
Denmark
-
Estonia
-
France
-
Germany
-
Greece
-
Hungary
-
Ireland
-
Italy
-
Latvia
-
Lithuania
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Estonian (PDF)
Published on: 3/03/2022