NELIO 5 MG TABLET FOR DOGS
NELIO 5 MG TABLET FOR DOGS
Authorised
- Benazepril hydrochloride
Product identification
Medicine name:
NELIO 5 MG TABLET FOR DOGS
NELIO 5 mg, comprimate pentru câini
Active substance:
- Benazepril hydrochloride
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Benazepril hydrochloride5.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Tablet
Withdrawal period by route of administration:
-
Oral use
- Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QC09AA07
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
Romania
Package description:
- Cardboard box with 5 blister strips of 10 tablets
- Cardboard box with 10 blister strips of 10 tablets
- Cardboard box with 25 blister strips of 10 tablets
- Cardboard box with 1 blister strip of 10 tablets
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:
- Ceva Sante Animale Romania S.R.L.
Marketing authorisation date:
Manufacturing sites for batch release:
- Ceva Sante Animale
Responsible authority:
- Institute For Control Of Biological Products And Veterinary Medicines
Authorisation number:
- 160385
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0205/001
Concerned member states:
-
Austria
-
Belgium
-
Denmark
-
Finland
-
Germany
-
Greece
-
Ireland
-
Italy
-
Luxembourg
-
Netherlands
-
Poland
-
Portugal
-
Romania
-
Spain
-
United Kingdom (Northern Ireland)
To consult adverse reactions on veterinary medicinal products please go to www.adrreports.eu/vet
Documents
Summary of Product Characteristics
This document does not exist in this language (English). You can find it in another language below.
Romanian (PDF)
Published on: 23/01/2024
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