DANIDOL 150 mg/ml solution for injection for cattle
DANIDOL 150 mg/ml solution for injection for cattle
Suspended
- Ketoprofen
Product identification
Medicine name:
EDERAL 150 mg/ml SOLUCION INYECTABLE PARA BOVINO PORCINO Y CABALLOS
DANIDOL 150 mg/ml solution for injection for cattle
Active substance:
- Ketoprofen
Target species:
-
Cattle
-
Horse
-
Pig
Route of administration:
-
Intramuscular use
-
Intravenous use
Product details
Active substance and strength:
-
Ketoprofen150.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Withdrawal period by route of administration:
-
Intramuscular use
- Cattle
- Horse
- Pig
-
Intravenous use
- Cattle
- Horse
- Pig
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QM01AE03
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Suspended
Authorised in:
-
Spain
Package description:
- box containing 5 vials of 250 ml
- box containing 10 vials of 100 ml
- box containing 5 vials of 100 ml
- box containing 1 vial of 250 ml
- box containing 1 vial of 100 ml
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Informed consent application (Article 13c of Directive No 2001/82/EC)
Marketing authorisation holder:
- Ecuphar Veterinaria S.L.U.
Marketing authorisation date:
Manufacturing sites for batch release:
- Zoetis Manufacturing & Research Spain S.L.
Responsible authority:
- (AEMPS)
Authorisation number:
- 2313 ESP
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0169/001
Concerned member states:
-
Austria
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
English (PDF)
Download Published on: 6/04/2023
Spanish (PDF)
Published on: 17/03/2023
Package Leaflet and Labelling
English (PDF)
Download Published on: 3/05/2022
Labelling
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
Package Leaflet
This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 17/03/2023
Combined File of all Documents
English (PDF)
Download Published on: 21/11/2022
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