Veterinary Medicines

AMODIP 1.25 MG CHEWABLE TABLETS FOR CATS

Authorised
  • Amlodipine besilate
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Product identification

Medicine name:
AMODIP 1.25 MG CHEWABLE TABLETS FOR CATS
Amodip 1.25 mg дъвчащи таблетки за котки
Active substance:
  • Amlodipine besilate
Target species:
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amlodipine besilate
    1.73
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Chewable tablet
Withdrawal period by route of administration:
  • Oral use
    • Cat
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QC08CA01
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Bulgaria
Available in:
  • Bulgaria
Package description:
  • Box containing 3 blister packs of 10 chewable tablets
  • Box containing 20 blister packs of 10 chewable tablets
  • Box containing 10 blister packs of 10 chewable 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 Animal Health Bulgaria EOOD
Marketing authorisation date:
Manufacturing sites for batch release:
  • Ceva Sante Animale
Responsible authority:
  • Bulgarian Food Safety Authority
Authorisation number:
  • 0022-2891
Date of authorisation status change:
Reference member state:
  • France
Procedure number:
  • FR/V/0413/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Hungary
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 23/03/2022
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Package Leaflet and Labelling

This document does not exist in this language (English). You can find it in another language below.
Bulgarian (PDF)
Published on: 23/03/2022
Download

Combined File of all Documents

English (PDF)
Published on: 13/12/2024
Download
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