Veterinary Medicines

Lodisure 1 mg tablets for cats

Authorised
  • Amlodipine besilate
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Product identification

Medicine name:
Lodisure 1 mg tablets for cats
Lodisure 1 mg Tablet
Lodisure 1 mg Comprimé
Lodisure 1 mg Tablette
Active substance:
  • Amlodipine besilate
Target species:
  • Cat
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Amlodipine besilate
    1.40
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • 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:
  • Belgium
Package description:
  • Blister made of PVC /aluminium / OPA with a push-through PVC-PVDC/aluminium lidding foil. Each blister contains 14 tablets.1 cardboard carton with 168 tablets.
  • Blister made of PVC /aluminium / OPA with a push-through PVC-PVDC/aluminium lidding foil. Each blister contains 14 tablets.1 cardboard carton with 28 tablets.
  • Blister made of PVC /aluminium / OPA with a push-through PVC-PVDC/aluminium lidding foil. Each blister contains 14 tablets.1 cardboard carton with 84 tablets.
  • Blister made of PVC /aluminium / OPA with a push-through PVC-PVDC/aluminium lidding foil. Each blister contains 14 tablets.1 cardboard carton with 56 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:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Lelypharma B.V.
Responsible authority:
  • Federal Agency For Medicines And Health Products
Authorisation number:
  • BE-V579733
Date of authorisation status change:
Reference member state:
  • Netherlands
Procedure number:
  • NL/V/0339/001
Concerned member states:
  • Austria
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Summary of Product Characteristics

English (PDF)
Published on: 20/09/2023
Updated on: 22/09/2023
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Dutch (PDF)
Published on: 12/01/2024
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French (PDF)
Published on: 12/01/2024
Download
German (PDF)
Published on: 12/01/2024
Download

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 12/01/2024
Download
French (PDF)
Published on: 12/01/2024
Download
German (PDF)
Published on: 12/01/2024
Download

Package Leaflet and Labelling

English (PDF)
Published on: 20/09/2023
Updated on: 22/09/2023
Download

Combined File of all Documents

English (PDF)
Published on: 5/10/2023
Updated on: 7/10/2023
Download

Labelling

This document does not exist in this language (English). You can find it in another language below.
Dutch (PDF)
Published on: 12/01/2024
Download
French (PDF)
Published on: 12/01/2024
Download
German (PDF)
Published on: 12/01/2024
Download
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