ROLENOL 50 mg/ml SOLUCIÓN INYECTABLE
ROLENOL 50 mg/ml SOLUCIÓN INYECTABLE
Authorised
- Closantel
Product identification
Medicine name:
ROLENOL 50 mg/ml SOLUCIÓN INYECTABLE
Active substance:
- Closantel
Target species:
-
Cattle
-
Sheep
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Closantel50.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Subcutaneous use
-
Cattle
-
Meat and offal54day
-
Milkno withdrawal periodLeche: No autorizado para emplear en ganado vacuno productor de leche para consumo hu-mano incluso durante el secado. No emplear durante el último trimestre de la gestación en novi-llas destinadas a la producción de leche para consumo humano
-
-
Sheep
-
Meat and offal107day
-
Milkno withdrawal periodLeche: No autorizado para emplear en ovejas que producen leche para consumo humano inclu-so durante el secado. No emplear en el plazo de 1 año antes del primer parto en ovejas destina-das a la producción de leche para consumo humano
-
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP52AG09
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Spain
Available in:
-
Spain
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Industrial Veterinaria S.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Industrial Veterinaria S.A.
Responsible authority:
- Spanish Agency Of Medicines And Medical Devices
Authorisation number:
- 47 ESP
Date of authorisation status change:
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.
Spanish (PDF)
Published on: 27/02/2024
Package Leaflet
This document does not exist in this language (English). You can find it
in another language below.
Spanish (PDF)
Published on: 27/02/2024
Labelling
This document does not exist in this language (English). You can find it
in another language below.
Spanish (PDF)
Published on: 27/02/2024
