Soliphen 60 mg tablets for dogs
Soliphen 60 mg tablets for dogs
Authorised
- Phenobarbital
Product identification
Medicine name:
SOLIPHEN 60 mg comprimidos para cães
Soliphen 60 mg tablets for dogs
Active substance:
- Phenobarbital
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Phenobarbital60.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Tablet
Withdrawal period by route of administration:
-
Oral use
-
Dog
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QN03AA02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Portugal
Package description:
- (ID3) 300 Tablet: unspecified outer container with 25 Blister (PolyVinyl Chloride) each with 12 Tablet
- (ID2) 180 Tablet: unspecified outer container with 15 Blister (PolyVinyl Chloride) each with 12 Tablet
- (ID1) 60 Tablet: unspecified outer container with 5 Blister (PolyVinyl Chloride) each with 12 Tablet
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:
- Domes Pharma
Marketing authorisation date:
Manufacturing sites for batch release:
- Europeenne De Pharmacotechnie Europhartech
Responsible authority:
- Directorate General For Food And Veterinary
Authorisation number:
- 916/01/15DFVPT
Date of authorisation status change:
Reference member state:
-
Germany
Procedure number:
- DE/V/0305/001
Concerned member states:
-
Austria
-
Belgium
-
France
-
Italy
-
Luxembourg
-
Netherlands
-
Portugal
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Combined File of all Documents
English (PDF)
Download Published on: 17/04/2024
Portuguese (PDF)
Published on: 5/12/2024
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