ANTISHMANIA, 300 mg/ml, solution for injection for dogs.
ANTISHMANIA, 300 mg/ml, solution for injection for dogs.
Authorised
- Meglumine antimonate
Product identification
Medicine name:
ANTISHMANIA, 300 mg/ml, solution for injection for dogs.
ANTISHMANIA 300 MG/ML SOLUTION INJECTABLE POUR CHIENS
Active substance:
- Meglumine antimonate
Target species:
-
Dog
Route of administration:
-
Subcutaneous use
Product details
Active substance and strength:
-
Meglumine antimonate300.00/milligram(s)1.00millilitre(s)
Pharmaceutical form:
-
Solution for injection
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QP51DX01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
France
Package description:
- box containing 5 vials of 5 ml
- box containing 10 vials of 5 ml
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:
- Fatro S.p.A.
Marketing authorisation date:
Manufacturing sites for batch release:
- Fatro S.p.A.
Responsible authority:
- French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
- FR/V/7989990 5/2016
Date of authorisation status change:
Reference member state:
-
Spain
Procedure number:
- ES/V/0232/001
Concerned member states:
-
France
-
Greece
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: 11/04/2023
French (PDF)
Published on: 17/03/2025
Package Leaflet
English (PDF)
Download Published on: 11/04/2023
Labelling
English (PDF)
Download Published on: 11/04/2023
Package Leaflet and Labelling
This document does not exist in this language (English). You can find it
in another language below.
French (PDF)
Published on: 15/10/2025
Combined File of all Documents
English (PDF)
Download Published on: 24/07/2025
eu-PUAR-antishmania--300-mg-ml--solution-for-injection-for-dogs.-en.pdf
English (PDF)
Download Published on: 11/04/2023
