Veterinary Medicines

Milbactor 12.5 mg/125 mg tablets for dogs weighing at least 5 kg

Authorised
  • Milbemycin oxime
  • Praziquantel
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Product identification

Medicine name:
Milbactor 12,5 mg/125 mg comprimidos para cães com peso mínimo de 5 kg
Milbactor 12.5 mg/125 mg tablets for dogs weighing at least 5 kg
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:
  • 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:
  • Portugal
Package description:
  • 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.
Responsible authority:
  • Directorate General For Food And Veterinary
Authorisation number:
  • 842/02/14DFVPT
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0463/002
Concerned member states:
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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Combined File of all Documents

This document does not exist in this language (English). You can find it in another language below.
Portuguese (PDF)
Published on: 15/03/2022
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