Benadil, 5mg, Film-coated tablet
Benadil, 5mg, Film-coated tablet
Authorised
- Benazepril hydrochloride
Product identification
Medicine name:
Benadil, 5mg, Film-coated tablet
BENADIL 5 mg, filmom obalené tablety pre psy a mačky
Active substance:
- Benazepril hydrochloride
Target species:
-
Cat
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Benazepril hydrochloride5.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Film-coated tablet
Withdrawal period by route of administration:
-
Oral use
- Cat
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QC09AA07
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Slovakia
Package description:
- Aluminum/Plastic Blister 7 x 14.0 Tablet
- Aluminum/Plastic Blister 2 x 14.0 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:
- Vetviva Richter GmbH
Marketing authorisation date:
Manufacturing sites for batch release:
- Richter Pharma AG
Responsible authority:
- Institute For State Control Of Veterinary Biologicals And Medicaments
Authorisation number:
- 96/064/DC/12-S
Date of authorisation status change:
Reference member state:
-
Czechia
Procedure number:
- CZ/V/0111/002
Concerned member states:
-
Belgium
-
France
-
Germany
-
Hungary
-
Luxembourg
-
Netherlands
-
Poland
-
Portugal
-
Slovakia
-
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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Slovak (PDF)
Published on: 9/04/2024
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