Phenoleptil 100 mg Tablets for dogs
Phenoleptil 100 mg Tablets for dogs
Authorised
- Phenobarbital
Product identification
Medicine name:
Phenoleptil 100 mg Tablets for dogs
Phenoleptil 100 mg tabletter
Active substance:
- Phenobarbital
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Phenobarbital100.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN03AA02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Denmark
Package description:
- 100 tablets in a cardboard carton containing 10 aluminium/PVC/PE/PVdC blister strips each strip with 10 tablets.
- 500 tablets in a cardboard carton containing 50 aluminium/PVC/PE/PVdC blister strips each strip with 10 tablets.
- 500 tablets in a cardboard carton containing 50 aluminium/pvc blister strips eachstrip with 10 tablets.
- 100 tablets in a cardboard carton containing 10 aluminium/pvc blister strips each strip with 10 tablets.
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Lelypharma B.V.
- Genera d.d.
Responsible authority:
- Danish Medicines Agency
Authorisation number:
- 49973
Date of authorisation status change:
Reference member state:
-
Ireland
Procedure number:
- IE/V/0635/004
Concerned member states:
-
Austria
-
Belgium
-
Croatia
-
Czechia
-
Denmark
-
Finland
-
France
-
Germany
-
Hungary
-
Iceland
-
Italy
-
Luxembourg
-
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
