Phenotab 100 mg
Phenotab 100 mg
Authorised
- Phenobarbital
Product identification
Medicine name:
Phenotab 100 mg
Epibarb Vet. 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
Available in:
-
Denmark
Package description:
- Aluminum / PVC/PE/PVDC blister pack with 10 tablets in a cardboard box of 3 strips.
- Aluminum / PVC/PE/PVDC blister pack with 10 tablets in a cardboard box of 5 strips.
- Aluminum / PVC/PE/PVDC blister pack with 10 tablets in a cardboard box of 25 strips.
- Aluminum / PVC/PE/PVDC blister pack with 10 tablets in a cardboard box of 10 strips.
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:
- CP-Pharma Handelsgesellschaft mbH
Marketing authorisation date:
Manufacturing sites for batch release:
- CP-Pharma Handelsgesellschaft mbH
Responsible authority:
- Danish Medicines Agency
Authorisation number:
- 62826
Date of authorisation status change:
Reference member state:
-
Netherlands
Procedure number:
- NL/V/0330/003
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Finland
-
France
-
Germany
-
Hungary
-
Ireland
-
Italy
-
Poland
-
Portugal
-
Spain
-
Sweden
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
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Danish (, TABLETTER 25 MG, 60 MG OG 100 MG)
Published on: 29/06/2023