Veterinary Medicine Information website

Amcofen 12.5 mg/125 mg film-coated tablets for dogs weighing at least 5 kg

Authorised
  • Milbemycin oxime
  • Praziquantel
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Product identification

Medicine name:
Amcofen 12.5 mg/125 mg film-coated 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:
  • 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:
  • Poland
Available in:
  • Poland
Package description:
  • Blister packs consisting of cold formed aluminium foil which consists of aluminum layer coated with OPA (Oriented Polyamide) film on one side and PVC on the other side and an aluminum sealing foil.Package sizes:Cardboard box with 12 blisters, each blister contains 4 tablets (total 48 tablets).
  • Blister packs consisting of cold formed aluminium foil which consists of aluminum layer coated with OPA (Oriented Polyamide) film on one side and PVC on the other side and an aluminum sealing foil.Package sizes:Cardboard box with 1 blister of 4 tablets.
  • Blister packs consisting of cold formed aluminium foil which consists of aluminum layer coated with OPA (Oriented Polyamide) film on one side and PVC on the other side and an aluminum sealing foil.Package sizes:Cardboard box with 1 blister of 2 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:
  • Office For Registration Of Medicinal Products Medical Devices And Biocidal Products
Authorisation number:
  • 3145
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0524/004
Concerned member states:
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • France
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 8/05/2025
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Labelling

This document does not exist in this language (English). You can find it in another language below.
Polish (PDF)
Published on: 8/05/2025
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Summary of Product Characteristics

English (PDF)
Published on: 26/08/2024
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Polish (PDF)
Published on: 8/05/2025
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