Veterinary Medicines

PRILENAL 5 MG, TABLETS

Not authorised
  • Enalapril maleate
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Product identification

Medicine name:
PRILENAL 5 MG, TABLETS
Prilenal 5 mg, tabletten
Active substance:
  • Enalapril maleate
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Enalapril maleate
    5.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC09AA02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Surrendered
Authorised in:
  • Netherlands
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 B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
  • Europeenne De Pharmacotechnie Europhartech
Responsible authority:
  • Medicines Evaluation Board
Authorisation number:
  • REG NL 10311
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0152/003

Documents

Combined File of all Documents

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Dutch (PDF)
Published on: 14/04/2022
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