Amcofen 2.5 mg/25 mg film-coated tablets for small dogs and puppies weighing at least 0.5 kg
Amcofen 2.5 mg/25 mg film-coated tablets for small dogs and puppies weighing at least 0.5 kg
Authorised
- Milbemycin oxime
- Praziquantel
Product identification
Medicine name:
Amcofen 2.5 mg/25 mg film-coated tablets for small dogs and puppies weighing at least 0.5 kg
Active substance:
- Milbemycin oxime
- Praziquantel
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Milbemycin oxime2.50/milligram(s)1.00Tablet
-
Praziquantel25.00/milligram(s)1.00Tablet
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:
-
Belgium
Available in:
-
Belgium
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-Farma d.o.o.
- KRKA tovarna zdravil d.d. Novo mesto
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V592142
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0524/003
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)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
This document does not exist in this language (English). You can find it
in another language below.
Labelling
This document does not exist in this language (English). You can find it
in another language below.
