Veterinary Medicines

Milprazon 2.5 mg/25 mg tablets for small dogs and puppies weighing at least 0.5 kg

Authorised
  • Milbemycin oxime
  • Praziquantel
Download as PDF

Product identification

Medicine name:
Milprazon 2.5 mg/25 mg tablets for small dogs and puppies weighing at least 0.5 kg
Milprazon 2,5 mg/25 mg tablety pre malé psy a šteňatá s hmotnosťou najmenej 0,5 kg
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:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB51
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Slovakia
Package description:
  • Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil. Box with 1 blister of 2 tablets.
  • Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil. Box with 1 blister of 4 tablets.
  • Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil. Box with 12 blisters, each blister contains 4 tablets.

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:
  • KRKA tovarna zdravil d.d. Novo mesto
Marketing authorisation date:
Manufacturing sites for batch release:
  • KRKA tovarna zdravil d.d. Novo mesto
  • Krka-Farma d.o.o.
  • TAD Pharma GmbH
Responsible authority:
  • Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
  • 96/079/DC/14-S
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0462/001
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Cyprus
  • Czechia
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Slovak (PDF)
Published on: 22/04/2025
Download

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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."