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MILBEMYCIN OXIME PRAZIQUANTEL ALFAMED I2,5 MG / 25 MG FILM COATED TABLETS FOR SMALL DOGS AND PUPPIES

Authorised
  • Milbemycin oxime
  • Praziquantel
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Product identification

Medicine name:
MILBEMYCIN OXIME PRAZIQUANTEL ALFAMED I2,5 MG / 25 MG FILM COATED TABLETS FOR SMALL DOGS AND PUPPIES
Active substance:
  • Milbemycin oxime
  • Praziquantel
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Milbemycin oxime
    2.50
    milligram(s)
    /
    1.00
    Tablet
  • Praziquantel
    25.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Film-coated tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB51
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Estonia
Package description:
  • 1 box of 24 tablets containing 12 blisters of 2 tablets (divisible per tablet)

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 France
Responsible authority:
  • State Agency Of Medicines
Authorisation number:
  • 1173224
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0478/003
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • Sweden

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Estonian (PDF)
Published on: 29/10/2024
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