Clavudale 400 mg/100 mg tablets for dogs
Clavudale 400 mg/100 mg tablets for dogs
Authorised
- Amoxicillin trihydrate
- Potassium clavulanate
Product identification
Medicine name:
Clavudale 400 mg/100 mg tablets for dogs
Clavudale 400 mg - 100 mg Tablet
Clavudale 400 mg - 100 mg Comprimé
Clavudale 400 mg - 100 mg Tablette
Active substance:
- Amoxicillin trihydrate
- Potassium clavulanate
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Amoxicillin trihydrate459.22/milligram(s)1.00Tablet
-
Potassium clavulanate119.13/milligram(s)1.00Tablet
Pharmaceutical form:
-
Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QJ01CR02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Belgium
Package description:
- Blister packs consisting of orientated Polyamide/Aluminium/Polyvinyl chloride film, heat sealed with aluminium foil (25micrometer) in strips of 6 tablets. Cartons containing 12 tablets.
- Blister packs consisting of orientated Polyamide/Aluminium/Polyvinyl chloride film, heat sealed with aluminium foil (25micrometer) in strips of 6 tablets. Cartons containing 24 tablets.
- Blister packs consisting of orientated Polyamide/Aluminium/Polyvinyl chloride film, heat sealed with aluminium foil (25micrometer) in strips of 6 tablets. Cartons containing 120 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:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Genera d.d.
- Laboratorio Reig Jofre S.A.
Responsible authority:
- Federal Agency For Medicines And Health Products
Authorisation number:
- BE-V567022
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0504/003
Concerned member states:
-
Austria
-
Belgium
-
Croatia
-
Czechia
-
Denmark
-
Finland
-
France
-
Germany
-
Greece
-
Hungary
-
Iceland
-
Italy
-
Luxembourg
-
Netherlands
-
Norway
-
Poland
-
Portugal
-
Slovakia
-
Slovenia
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Package Leaflet
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Labelling
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