Veterinary Medicines

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

Authorised
  • Milbemycin oxime
  • Praziquantel
Download as PDF

Product identification

Medicine name:
Amcofen 12.5 mg/125 mg film-coated tablets for dogs weighing at least 5 kg
Amcofen 12,5 mg/125 mg, kramtomosios tabletės ne mažiau kaip 5 kg sveriantiems šunims
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
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:
  • Lithuania
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 1 blister of 2 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 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:
  • Krka d.d. Novo Mesto
  • Krka-Farma d.o.o.
Responsible authority:
  • State Food And Veterinary Service
Authorisation number:
  • LT/2/19/2534/001-003
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0524/004
Concerned member states:
  • Belgium
  • Bulgaria
  • 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
Download

RV2534.pdf

Lithuanian (PDF)
Published on: 30/05/2022
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."