Veterinary Medicines

MILBEMYCINE OXIME PRAZIQUANTEL ALFAMED II 12,5 MG/125 MG COMPRIMES PELLICULES POUR CHIENS

Authorised
  • Milbemycin oxime
  • Praziquantel
Download as PDF

Product identification

Medicine name:
MILBEMYCINE OXIME PRAZIQUANTEL ALFAMED II 12,5 MG/125 MG COMPRIMES PELLICULES POUR CHIENS
Active substance:
  • Milbemycin oxime
  • Praziquantel
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Milbemycin oxime
    12.50
    milligram(s)
    /
    1.00
    Tablet
  • Praziquantel
    125.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Film-coated tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB51
Legal status of supply:
  • Veterinary medicinal product not subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application - change in active substance(s) (Article 19(1)(a) of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Alfamed
Marketing authorisation date:
Manufacturing sites for batch release:
  • Alfamed
  • Virbac
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/3125361 5/2024
Date of authorisation status change:

Documents

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: 23/04/2025
Download

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
French (PDF)
Published on: 23/04/2025
Download
How useful was this page?:
No votes yet
"Please do not include any personal data, such as your name or contact details. If you do, you consent to the processing of that data in accordance with EMA’s Privacy Statement concerning requests for information or access to documents. If you would like a reply from EMA, please Send a question to EMA instead."