PRILACTONE NEXT 50 MG CHEWABLE TABLETS FOR DOGS
PRILACTONE NEXT 50 MG CHEWABLE TABLETS FOR DOGS
Authorised
- Spironolactone
Product identification
Medicine name:
PRILACTONE NEXT 50 MG CHEWABLE TABLETS FOR DOGS
Prilactone Next 50 mg kauwtabletten voor honden
Active substance:
- Spironolactone
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Spironolactone50.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Chewable tablet
Withdrawal period by route of administration:
-
Oral use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QC03DA01
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Netherlands
Package description:
- Cardboard box with 1 blister of 10 tablets
- Cardboard box with 2 blisters of 10 tablets
- Cardboard box with 3 blisters of 10 tablets
- Cardboard box with 10 blisters of 10 tablets
- Cardboard box with 18 blisters of 10 tablets
Additional information
Entitlement type:
-
Marketing Authorisation
Legal basis of product authorisation:
-
Full application - Known active substance (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
- CEVA Sante Animale B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
- Ceva Sante Animale
Responsible authority:
- Medicines Evaluation Board
Authorisation number:
- REG NL 109555
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0235/002
Concerned member states:
-
Austria
-
Belgium
-
Finland
-
Germany
-
Greece
-
Ireland
-
Italy
-
Luxembourg
-
Netherlands
-
Poland
-
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
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Dutch (PDF)
Published on: 14/04/2022
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