Veterinary Medicines

Libromide 325 mg tablets for dogs

Authorised
  • Potassium bromide
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Product identification

Medicine name:
Libromide 325 mg tablets for dogs
Libromide 325 mg Tabletten für Hunde
Active substance:
  • Potassium bromide
Target species:
  • Dog
Route of administration:
  • Oral use

Product details

Active substance and strength:
  • Potassium bromide
    325.00
    milligram(s)
    /
    1.00
    Tablet
Pharmaceutical form:
  • Tablet
Withdrawal period by route of administration:
  • Oral use
    • Dog
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QN05CM11
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Austria
Package description:

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Full application (Article 12(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Dechra Regulatory B.V.
Marketing authorisation date:
Manufacturing sites for batch release:
  • Genera d.d.
Responsible authority:
  • Austrian Agency For Health And Food Safety
Authorisation number:
  • 8-01171
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0507/001
Concerned member states:
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Luxembourg
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
  • United Kingdom (Northern Ireland)

Documents

Package Leaflet

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 13/08/2024
Updated on: 2/09/2024
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Summary of Product Characteristics

English (PDF)
Published on: 3/05/2024
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German (PDF)
Published on: 14/11/2023
Updated on: 2/09/2024
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Labelling

This document does not exist in this language (English). You can find it in another language below.
German (PDF)
Published on: 1/03/2019
Updated on: 2/09/2024
Download
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