Veterinary Medicines

MILBETAB 12,5 MG/125 MG CHEWABLE TABLETS FOR DOGS

Authorised
  • Milbemycin oxime
  • Praziquantel
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Product identification

Medicine name:
MILBETAB 12,5 MG/125 MG CHEWABLE TABLETS FOR DOGS
MILBETAB 12,5 MG/125 MG COMPRIMES A CROQUER 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:
  • Chewable tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB51
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription except for some pack sizes
Authorisation status:
  • Valid
Authorised in:
  • France
Package description:
  • Box with 1 blister strip of 4 chewable tablets
  • Box with 2 blister strip of of 5 chewable tablets
  • Box with of 3 blisters strips of 4 chewable tablets
  • Box with 5 blister strips of 4 chewable tablets
  • Box with 6 blisters strips of 4 chewable tablets
  • Box with 12 blister strips of 4 chewable tablets
  • 1 box with 1 blister of 2 chewable tablets
  • Box with 2 blister strips of 2 chewable tablets
  • Box with 1 blister strips of 5 chewable tablets
  • Box with 5 blisters strips of 2 chewable tablets
  • Box with of 6 blister strips of 2 chewable tablets
  • Box with 3 blister strips of 5 chewable tablets
  • Box with 10 blisters strips of 2 chewable tablets
  • Box with 12 blister strips of 2 chewable tablets
  • Box with 5 blister strips of 5 chewable tablets,
  • Box with 6 blister strips of 5 chewable tablets
  • Box with 7 blister strips of 5 chewable tablets
  • Box with 8 blister strips of 5 chewable tablets
  • Box with 9 blister strips of 5 chewable tablets
  • Box with 24 blisters strips of 2 chewable tablets
  • Box with 10 blister strips of 5 chewable tablets

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Generic application (Article 18 of Regulation (EU) 2019/6)
Marketing authorisation holder:
  • Chanelle Pharmaceuticals Manufacturing Limited
Marketing authorisation date:
Manufacturing sites for batch release:
  • Chanelle Pharmaceuticals Manufacturing Limited
Responsible authority:
  • French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
  • FR/V/9207167 8/2025
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0488/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Finland
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
Generic of:

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: 22/09/2025
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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: 22/09/2025
Download

eu-puar-frv0488001-mr-rpe916-en.pdf

English (PDF)
Published on: 7/01/2026
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15835 FR V 0488 001 DC PuAR.pdf

English (PDF)
Published on: 29/09/2025
Download