PRILENAL 5 MG, TABLETS
PRILENAL 5 MG, TABLETS
Authorised
- Enalapril maleate
Product identification
Medicine name:
PRILENAL 8 - 15 KG
PRILENAL 5 MG, TABLETS
Active substance:
- Enalapril maleate
Target species:
-
Dog
Route of administration:
-
Oral use
Product details
Active substance and strength:
-
Enalapril maleate5.00/milligram(s)1.00Tablet
Pharmaceutical form:
-
Tablet
Withdrawal period by route of administration:
-
Oral use
-
Dog
-
Anatomical therapeutic chemical veterinary (ATCvet) codes:
- QC09AA02
Legal status of supply:
-
Veterinary medicinal product subject to veterinary prescription
Authorisation status:
-
Valid
Authorised in:
-
France
Package description:
- Box containing 12 blisters of 7 tablets
- Box containing 24 blisters of 7 tablets
- Box containing 4 blisters of 7 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
Marketing authorisation date:
Manufacturing sites for batch release:
- Ceva Sante Animale
- Europeenne De Pharmacotechnie Europhartech
Responsible authority:
- French Agency For Food, Environmental And Occupational Health & Safety
Authorisation number:
- FR/V/9458574 0/2004
Date of authorisation status change:
Reference member state:
-
France
Procedure number:
- FR/V/0152/003
Concerned member states:
-
Austria
-
Belgium
-
Czechia
-
Germany
-
Greece
-
Italy
-
Luxembourg
-
Netherlands
-
Portugal
-
Slovakia
-
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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in another language below.
French (PDF)
Published on: 4/04/2022
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