Veterinary Medicines

MILTEFOSINA VIRBAC 20 mg/ml ORAL SOLUTION FOR DOGS

Authorised
  • Miltefosine
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Product identification

Medicine name:
MILTEFOSINA VIRBAC 20 mg/ml ORAL SOLUTION FOR DOGS
MILTEFOSINA VIRBAC 20 mg/ml SOLUCION ORAL PARA PERROS
Active substance:
  • Miltefosine
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Miltefosine
    20.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Oral solution
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP51D
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Spain
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application - New active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Virbac
Marketing authorisation date:
Manufacturing sites for batch release:
  • Virbac
Responsible authority:
  • Spanish Agency Of Medicines And Medical Devices
Authorisation number:
  • 1761 ESP
Date of authorisation status change:
Reference member state:
  • Spain
Procedure number:
  • ES/V/0116/001
Concerned member states:
  • Cyprus
  • Greece
  • Italy
  • Portugal
  • Slovenia

Documents

Summary of Product Characteristics

English (PDF)
Published on: 30/10/2025
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Spanish (PDF)
Published on: 2/02/2024
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Combined File of all Documents

English (PDF)
Published on: 24/07/2025
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Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 2/02/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Spanish (PDF)
Published on: 2/02/2024
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es-puar-milteforan-20-mg-ml-es.pdf

Spanish (PDF)
Published on: 17/03/2023
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