Veterinary Medicines

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

Authorised
  • Milbemycin oxime
  • Praziquantel
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Product identification

Medicine name:
Amcofen 2.5 mg/25 mg chewable tablets for small dogs and puppies weighing at least 0.5 kg
AMCOFEN 2,5 mg/25 mg comprimate masticabile pentru cainii de talie mica si catei cu greutate de cel putin 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:
  • Chewable tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QP54AB51
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Romania
Package description:
  • Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil.Cardboard box with 1 blister of 2 tablets.
  • Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil.Cardboard box with 1 blister of 4 tablets.
  • Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil.Cardboard box with 12 blisters, each blister contains 4 tablets (total 48 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:
  • TAD Pharma GmbH
  • KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
  • Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
  • 240085
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0524/001
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

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.
Romanian (PDF)
Published on: 23/07/2024
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